Viewing Study NCT00454818

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Ignite Creation Date: 2025-12-25 @ 4:39 AM
Ignite Modification Date: 2025-12-26 @ 3:42 AM
Study NCT ID: NCT00454818
Status: COMPLETED
Last Update Posted: 2014-08-20
First Post: 2007-03-30
Is NOT Gene Therapy: False
Has Adverse Events: True
Brief Title: Efficacy and Safety Study of Genetically Targeted Enzyme Replacement Therapy for Advanced Heart Failure
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D002311', 'term': 'Cardiomyopathy, Dilated'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006332', 'term': 'Cardiomegaly'}, {'id': 'D009202', 'term': 'Cardiomyopathies'}, {'id': 'D000083083', 'term': 'Laminopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jrudy@celladon.net', 'phone': '1 858-366-4288', 'title': 'Jeffrey J. Rudy, Vice President', 'organization': 'Celladon Corporation'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Limitations of this study include its small sample size and the inability to conclusively prove that the delivered gene was responsible for the observed clinical effects. Larger confirmatory trials are needed.'}}, 'adverseEventsModule': {'timeFrame': 'All treatment-emergent adverse events (TEAEs) that occurred from the time of first infusion of the investigational product or placebo through the 12-month visit.', 'description': 'These data include all TEAEs occurring during the Phase 1 or Phase 2 parts of this study.', 'eventGroups': [{'id': 'EG000', 'title': 'MYDICAR® Very Low Dose', 'description': 'Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \\[AAV1\\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1.4E11DRP administered by antegrade epicardial coronary artery infusion.', 'otherNumAtRisk': 3, 'otherNumAffected': 2, 'seriousNumAtRisk': 3, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'MYDICAR® Low Dose', 'description': 'Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \\[AAV1\\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11DRP administered by antegrade epicardial coronary artery infusion.', 'otherNumAtRisk': 11, 'otherNumAffected': 11, 'seriousNumAtRisk': 11, 'seriousNumAffected': 6}, {'id': 'EG002', 'title': 'MYDICAR® Mid Dose', 'description': 'Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \\[AAV1\\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.', 'otherNumAtRisk': 11, 'otherNumAffected': 11, 'seriousNumAtRisk': 11, 'seriousNumAffected': 5}, {'id': 'EG003', 'title': 'MYDICAR® High Dose', 'description': 'Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \\[AAV1\\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.', 'otherNumAtRisk': 12, 'otherNumAffected': 11, 'seriousNumAtRisk': 12, 'seriousNumAffected': 4}, {'id': 'EG004', 'title': 'Placebo', 'description': 'Single dose of placebo administered by antegrade epicardial coronary artery infusion.', 'otherNumAtRisk': 14, 'otherNumAffected': 13, 'seriousNumAtRisk': 14, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Cardiac aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Cardiogenic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Intracardiac thrombus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Ventricular fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Hydrocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'External ear disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Epigastric discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Gastric ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Catheter site hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Catheter site hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Feeling jittery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Gait disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Infusion site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Edema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Puncture site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Venipuncture site 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'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 11.1'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 11.1'}, {'term': 'Brain stem stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 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{'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 11.1'}, {'term': 'Pneumonia staphylococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 11.1'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 11.1'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 11.1'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 11.1'}, {'term': 'Catheterization cardiac', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 11.1'}, {'term': 'Heart transplant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 11.1'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 11.1'}, {'term': 'Colonoscopy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 11.1'}, {'term': 'Colon cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 11.1'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 11.1'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 11.1'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Cardiogenic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Sudden death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Orthopnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Phase 2: Incidence of Treatment-emergent Adverse Events (TEAE) at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MYDICAR® Low Dose', 'description': 'Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \\[AAV1\\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.'}, {'id': 'OG001', 'title': 'MYDICAR® Mid Dose', 'description': 'Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \\[AAV1\\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.'}, {'id': 'OG002', 'title': 'MYDICAR® High Dose', 'description': 'Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \\[AAV1\\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Single dose of placebo administered by antegrade epicardial coronary artery infusion.'}], 'classes': [{'title': 'Any TEAE', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '88.9', 'groupId': 'OG002'}, {'value': '92.9', 'groupId': 'OG003'}]}]}, {'title': 'TEAEs related to the investigational product (IP)', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '12.5', 'groupId': 'OG001'}, {'value': '11.1', 'groupId': 'OG002'}, {'value': '57.1', 'groupId': 'OG003'}]}]}, {'title': 'TEAEs related to administration of the IP', 'categories': [{'measurements': [{'value': '12.5', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '11.1', 'groupId': 'OG002'}, {'value': '57.1', 'groupId': 'OG003'}]}]}, {'title': 'Serious TEAEs', 'categories': [{'measurements': [{'value': '62.5', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '33.3', 'groupId': 'OG002'}, {'value': '64.3', 'groupId': 'OG003'}]}]}, {'title': 'Serious TEAEs related to the IP', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '21.4', 'groupId': 'OG003'}]}]}, {'title': 'Serious TEAEs related to IP administration', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '28.6', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Includes all adverse events that occurred from the time of first infusion of the investigational product or placebo to the 12-month visit. The category of "TEAEs related to the investigational product (IP)" includes TEAEs considered by the investigator to be possibly, probably, or definitely related to the IP.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial.'}, {'type': 'PRIMARY', 'title': 'Phase 2: Length of Cardiovascular-related Hospitalizations at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MYDICAR® Low Dose', 'description': 'Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \\[AAV1\\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.'}, {'id': 'OG001', 'title': 'MYDICAR® Mid Dose', 'description': 'Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \\[AAV1\\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.'}, {'id': 'OG002', 'title': 'MYDICAR® High Dose', 'description': 'Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \\[AAV1\\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Single dose of placebo administered by antegrade epicardial coronary artery infusion.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.3', 'spread': '0.46', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '2.55', 'groupId': 'OG001'}, {'value': '0.2', 'spread': '0.67', 'groupId': 'OG002'}, {'value': '2.1', 'spread': '2.92', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.078', 'groupIds': ['OG002', 'OG003'], 'pValueComment': 'The a priori threshold for statistical significance was P \\< 0.2. There were no adjustments for multiple comparisons.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.515', 'groupIds': ['OG001', 'OG003'], 'pValueComment': 'The a priori threshold for statistical significance was P \\< 0.2. There were no adjustments for multiple comparisons.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.098', 'groupIds': ['OG000', 'OG003'], 'pValueComment': 'The a priori threshold for statistical significance was P \\< 0.2. There were no adjustments for multiple comparisons.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Mean number of days in the hospital for cardiovascular-related complications. All hospitalizations were evaluated and classified by the blinded Clinical Endpoints Committee.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial.'}, {'type': 'PRIMARY', 'title': 'Phase 2: Change in Symptomatic Efficacy Domains From Baseline to Month 6: New York Heart Association (NYHA) Class and Minnesota Living With Heart Failure Questionnaire (MLWHFQ) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MYDICAR® Low Dose', 'description': 'Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \\[AAV1\\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.'}, {'id': 'OG001', 'title': 'MYDICAR® Mid Dose', 'description': 'Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \\[AAV1\\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.'}, {'id': 'OG002', 'title': 'MYDICAR® High Dose', 'description': 'Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \\[AAV1\\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Single dose of placebo administered by antegrade epicardial coronary artery infusion.'}], 'classes': [{'title': 'Change in NHYA class', 'categories': [{'measurements': [{'value': '-0.8', 'spread': '0.71', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '0.89', 'groupId': 'OG001'}, {'value': '-0.6', 'spread': '0.73', 'groupId': 'OG002'}, {'value': '-0.2', 'spread': '0.70', 'groupId': 'OG003'}]}]}, {'title': 'Change in MLWHFQ score', 'categories': [{'measurements': [{'value': '-7.6', 'spread': '20.99', 'groupId': 'OG000'}, {'value': '7.9', 'spread': '27.28', 'groupId': 'OG001'}, {'value': '-10.3', 'spread': '12.21', 'groupId': 'OG002'}, {'value': '3.4', 'spread': '36.00', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 6 months', 'description': 'NYHA classification is a symptomatic assessment in which the investigator evaluates subjects on a scale ranging from Class I (subjects with no limitation of activities, no symptoms from ordinary activities) to Class IV (subjects who should be at complete rest, confined to bed or chair; any physical activity brings on discomfort and symptoms occur at rest).\n\nThe MLWHFQ is a patient-reported quality of life (QoL) measure in which patients assess the impact of their heart condition on activities in the past month using a Likert scale ranging from 0 (no effect) to 5 (very much effect). Higher scores thus indicate a lower QoL. The maximum (worst) score is 105 and the minimum (best) score is 0.\n\nFor both measures, changes from baseline with positive values indicate a worsening in symptoms and changes from baseline with negative values indicate an improvement in symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial.'}, {'type': 'PRIMARY', 'title': 'Phase 2: Change in 6-minute Walk Test (6MWT) From Baseline to Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MYDICAR® Low Dose', 'description': 'Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \\[AAV1\\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.'}, {'id': 'OG001', 'title': 'MYDICAR® Mid Dose', 'description': 'Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \\[AAV1\\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.'}, {'id': 'OG002', 'title': 'MYDICAR® High Dose', 'description': 'Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \\[AAV1\\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Single dose of placebo administered by antegrade epicardial coronary artery infusion.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.0', 'spread': '61.40', 'groupId': 'OG000'}, {'value': '-59.5', 'spread': '213.64', 'groupId': 'OG001'}, {'value': '1.0', 'spread': '99.69', 'groupId': 'OG002'}, {'value': '-86.6', 'spread': '164.30', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 6 months', 'description': 'The 6MWT measures the distance walked in meters during a 6-minute test. Higher values indicate a better functional status. Changes from baseline with negative values indicate a worsening in function and changes from baseline with positive values indicate an improvement in function.', 'unitOfMeasure': 'meters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial.'}, {'type': 'PRIMARY', 'title': 'Phase 2: Change in Peak Maximum Oxygen Consumption (VO2) From Baseline to Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MYDICAR® Low Dose', 'description': 'Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \\[AAV1\\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.'}, {'id': 'OG001', 'title': 'MYDICAR® Mid Dose', 'description': 'Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \\[AAV1\\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.'}, {'id': 'OG002', 'title': 'MYDICAR® High Dose', 'description': 'Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \\[AAV1\\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Single dose of placebo administered by antegrade epicardial coronary artery infusion.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.73', 'spread': '4.88', 'groupId': 'OG000'}, {'value': '-1.07', 'spread': '5.076', 'groupId': 'OG001'}, {'value': '-0.43', 'spread': '0,802', 'groupId': 'OG002'}, {'value': '-2.10', 'spread': '4.462', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 6 months', 'description': 'Peak VO2 is a measure of maximal oxygen consumption during cardiopulmonary exercise testing; this study used the modified Naughton treadmill protocol. Higher values indicate a better functional status. Changes from baseline with negative values indicate a worsening in function and changes from baseline with positive values indicate an improvement in function.', 'unitOfMeasure': 'mL/kg per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial.'}, {'type': 'PRIMARY', 'title': 'Phase 2: Change in Absolute Levels of N-terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) From Baseline to Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MYDICAR® Low Dose', 'description': 'Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \\[AAV1\\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.'}, {'id': 'OG001', 'title': 'MYDICAR® Mid Dose', 'description': 'Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \\[AAV1\\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.'}, {'id': 'OG002', 'title': 'MYDICAR® High Dose', 'description': 'Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \\[AAV1\\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Single dose of placebo administered by antegrade epicardial coronary artery infusion.'}], 'classes': [{'categories': [{'measurements': [{'value': '694.1', 'spread': '1444.94', 'groupId': 'OG000'}, {'value': '2073.1', 'spread': '4224.22', 'groupId': 'OG001'}, {'value': '-13.5', 'spread': '928.48', 'groupId': 'OG002'}, {'value': '5540.0', 'spread': '11,873.46', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 6 months', 'description': 'NT-proBNP is a biomarker for heart failure. Increased levels of this biomarker are associated with increased mortality and cardiovascular hospitalization in patients with heart failure.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial. NT-proBNP data were not available for 1 patient in the MYDICAR high dose group.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Phase 2: Length of Cardiovascular-related Hospitalizations at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MYDICAR® Low Dose', 'description': 'Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \\[AAV1\\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.'}, {'id': 'OG001', 'title': 'MYDICAR® Mid Dose', 'description': 'Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \\[AAV1\\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.'}, {'id': 'OG002', 'title': 'MYDICAR® High Dose', 'description': 'Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \\[AAV1\\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Single dose of placebo administered by antegrade epicardial coronary artery infusion.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.1', 'spread': '12.71', 'groupId': 'OG000'}, {'value': '7.4', 'spread': '11.80', 'groupId': 'OG001'}, {'value': '0.4', 'spread': '1.33', 'groupId': 'OG002'}, {'value': '4.5', 'spread': '5.80', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Mean number of days in the hospital for cardiovascular-related complications. All hospitalizations were evaluated and classified by the blinded Clinical Endpoints Committee.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Phase 2: Change in Symptomatic Efficacy Domains From Baseline to Month 12: New York Heart Association (NYHA) Class and Minnesota Living With Heart Failure Questionnaire (MLWHFQ) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MYDICAR® Low Dose', 'description': 'Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \\[AAV1\\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.'}, {'id': 'OG001', 'title': 'MYDICAR® Mid Dose', 'description': 'Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \\[AAV1\\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.'}, {'id': 'OG002', 'title': 'MYDICAR® High Dose', 'description': 'Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \\[AAV1\\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Single dose of placebo administered by antegrade epicardial coronary artery infusion.'}], 'classes': [{'title': 'Change in NHYA class', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.99', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.83', 'groupId': 'OG001'}, {'value': '-0.3', 'spread': '0.71', 'groupId': 'OG002'}, {'value': '0.1', 'spread': '0.73', 'groupId': 'OG003'}]}]}, {'title': 'Change in MLWHFQ score', 'categories': [{'measurements': [{'value': '24.4', 'spread': '37.3', 'groupId': 'OG000'}, {'value': '22.5', 'spread': '32.56', 'groupId': 'OG001'}, {'value': '0.1', 'spread': '23.80', 'groupId': 'OG002'}, {'value': '14.7', 'spread': '34.89', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 12 months', 'description': 'NYHA classification is a symptomatic assessment in which the investigator evaluates subjects on a scale ranging from Class I (subjects with no limitation of activities, no symptoms from ordinary activities) to Class IV (subjects who should be at complete rest, confined to bed or chair; any physical activity brings on discomfort and symptoms occur at rest).\n\nThe MLWHFQ is a patient-reported quality of life (QoL) measure in which patients assess the impact of their heart condition on activities in the past month using a Likert scale ranging from 0 (no effect) to 5 (very much effect). Higher scores thus indicate a lower QoL. The maximum (worst) score is 105 and the minimum (best) score is 0.\n\nFor both measures, changes from baseline with positive values indicate a worsening in symptoms and changes from baseline with negative values indicate an improvement in symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was performed on the intention to treat population, which included all patients randomized to treatment.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Phase 2: Change in 6-minute Walk Test (6MWT) From Baseline to Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MYDICAR® Low Dose', 'description': 'Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \\[AAV1\\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.'}, {'id': 'OG001', 'title': 'MYDICAR® Mid Dose', 'description': 'Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \\[AAV1\\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.'}, {'id': 'OG002', 'title': 'MYDICAR® High Dose', 'description': 'Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \\[AAV1\\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Single dose of placebo administered by antegrade epicardial coronary artery infusion.'}], 'classes': [{'categories': [{'measurements': [{'value': '-167.9', 'spread': '191.02', 'groupId': 'OG000'}, {'value': '-115.9', 'spread': '226.56', 'groupId': 'OG001'}, {'value': '-23.7', 'spread': '151.08', 'groupId': 'OG002'}, {'value': '-120.4', 'spread': '181.41', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 12 months', 'description': 'The 6MWT measures the distance walked in meters during a 6-minute test. Higher values indicate a better functional status. Changes from baseline with negative values indicate a worsening in function and changes from baseline with positive values indicate an improvement in function.', 'unitOfMeasure': 'meters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Phase 2: Change in Peak Maximum Oxygen Consumption (VO2) From Baseline to Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MYDICAR® Low Dose', 'description': 'Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \\[AAV1\\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.'}, {'id': 'OG001', 'title': 'MYDICAR® Mid Dose', 'description': 'Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \\[AAV1\\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.'}, {'id': 'OG002', 'title': 'MYDICAR® High Dose', 'description': 'Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \\[AAV1\\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Single dose of placebo administered by antegrade epicardial coronary artery infusion.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.00', 'spread': '4.733', 'groupId': 'OG000'}, {'value': '-3.31', 'spread': '5.473', 'groupId': 'OG001'}, {'value': '-1.57', 'spread': '3.677', 'groupId': 'OG002'}, {'value': '-2.75', 'spread': '5.084', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 12 months', 'description': 'Peak VO2 is a measure of maximal oxygen consumption during cardiopulmonary exercise testing; this study used the modified Naughton treadmill protocol. Higher values indicate a better functional status. Changes from baseline with negative values indicate a worsening in function and changes from baseline with positive values indicate an improvement in function.', 'unitOfMeasure': 'mL/kg per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial. Peak VO2 data were not available for one patient in the placebo group.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Phase 2: Change in Absolute Levels of N-terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) From Baseline to Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MYDICAR® Low Dose', 'description': 'Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \\[AAV1\\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.'}, {'id': 'OG001', 'title': 'MYDICAR® Mid Dose', 'description': 'Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \\[AAV1\\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.'}, {'id': 'OG002', 'title': 'MYDICAR® High Dose', 'description': 'Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \\[AAV1\\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Single dose of placebo administered by antegrade epicardial coronary artery infusion.'}], 'classes': [{'categories': [{'measurements': [{'value': '3689.1', 'spread': '5109.27', 'groupId': 'OG000'}, {'value': '8440.4', 'spread': '11270.44', 'groupId': 'OG001'}, {'value': '1756.3', 'spread': '4331.00', 'groupId': 'OG002'}, {'value': '11464.3', 'spread': '16866.55', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 12 months', 'description': 'NT-proBNP is a biomarker for heart failure. Increased levels of this biomarker are associated with increased mortality and cardiovascular hospitalization in patients with heart failure.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial. NT-proBNP data were not available for 1 patient in the MYDICAR high dose group.'}, {'type': 'POST_HOC', 'title': 'Phase 2: Selected Clinical Outcomes During 12-month Study Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MYDICAR® Low Dose', 'description': 'Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \\[AAV1\\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.'}, {'id': 'OG001', 'title': 'MYDICAR® Mid Dose', 'description': 'Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \\[AAV1\\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.'}, {'id': 'OG002', 'title': 'MYDICAR® High Dose', 'description': 'Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \\[AAV1\\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Single dose of placebo administered by antegrade epicardial coronary artery infusion.'}], 'classes': [{'title': 'Fatal cardiovascular event', 'categories': [{'measurements': [{'value': '12.5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '7.1', 'groupId': 'OG003'}]}]}, {'title': 'Worsening heart failure', 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}, {'value': '37.5', 'groupId': 'OG001'}, {'value': '22.2', 'groupId': 'OG002'}, {'value': '50.0', 'groupId': 'OG003'}]}]}, {'title': 'Myocardial infarction', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '14.3', 'groupId': 'OG003'}]}]}, {'title': 'Heart failure-related hospitalization', 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}, {'value': '37.5', 'groupId': 'OG001'}, {'value': '22.2', 'groupId': 'OG002'}, {'value': '42.9', 'groupId': 'OG003'}]}]}, {'title': 'Silent myocardial infarction', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Receipt of left ventricular assist device', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '12.5', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '14.3', 'groupId': 'OG003'}]}]}, {'title': 'Heart transplant', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '25.0', 'groupId': 'OG001'}, {'value': '11.1', 'groupId': 'OG002'}, {'value': '7.1', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Incidences of key clinical endpoints as adjudicated by the blinded Clinical Endpoint Committee.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Phase 2: Change in Percentage of Blood Ejected From the Left Ventricle (LV) (i.e., Left Ventricular Ejection Fraction [LVEF]) From Baseline to Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MYDICAR® Low Dose', 'description': 'Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \\[AAV1\\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.'}, {'id': 'OG001', 'title': 'MYDICAR® Mid Dose', 'description': 'Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \\[AAV1\\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.'}, {'id': 'OG002', 'title': 'MYDICAR® High Dose', 'description': 'Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \\[AAV1\\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Single dose of placebo administered by antegrade epicardial coronary artery infusion.'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.5', 'spread': '7.26', 'groupId': 'OG000'}, {'value': '-5.6', 'spread': '10.52', 'groupId': 'OG001'}, {'value': '0.3', 'spread': '8.87', 'groupId': 'OG002'}, {'value': '-2.5', 'spread': '9.96', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 12 months', 'description': 'Contrast echocardiography was used to determine LVEF. Increases in LVEF are associated with reduced mortality. Changes from baseline with positive values indicate an improvement in heart function and changes from baseline with negative values indicate a worsening of heart function.', 'unitOfMeasure': 'Percentage of blood ejected from the LV', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial.'}, {'type': 'PRIMARY', 'title': 'Phase 2: Change in Percentage of Blood Ejected From the Left Ventricle (LV) (i.e., Left Ventricular Ejection Fraction [LVEF]) From Baseline to Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MYDICAR® Low Dose', 'description': 'Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \\[AAV1\\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.'}, {'id': 'OG001', 'title': 'MYDICAR® Mid Dose', 'description': 'Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \\[AAV1\\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.'}, {'id': 'OG002', 'title': 'MYDICAR® High Dose', 'description': 'Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \\[AAV1\\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Single dose of placebo administered by antegrade epicardial coronary artery infusion.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'spread': '1.87', 'groupId': 'OG000'}, {'value': '-1.5', 'spread': '6.35', 'groupId': 'OG001'}, {'value': '-0.7', 'spread': '3.76', 'groupId': 'OG002'}, {'value': '-2.1', 'spread': '6.90', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 6 months', 'description': 'Contrast echocardiography was used to determine LVEF. Increases in LVEF are associated with reduced mortality. Changes from baseline with positive values indicate an improvement in heart function and changes from baseline with negative values indicate a worsening of heart function.', 'unitOfMeasure': 'Percentage of blood ejected from the LV', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial.'}, {'type': 'PRIMARY', 'title': 'Phase 2: Change in Absolute Left Ventricular End Systolic Volume (LVESV) Frm Baseline to Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MYDICAR® Low Dose', 'description': 'Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \\[AAV1\\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.'}, {'id': 'OG001', 'title': 'MYDICAR® Mid Dose', 'description': 'Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \\[AAV1\\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.'}, {'id': 'OG002', 'title': 'MYDICAR® High Dose', 'description': 'Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \\[AAV1\\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Single dose of placebo administered by antegrade epicardial coronary artery infusion.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.4', 'spread': '26.16', 'groupId': 'OG000'}, {'value': '10.5', 'spread': '45.91', 'groupId': 'OG001'}, {'value': '-9.6', 'spread': '27.55', 'groupId': 'OG002'}, {'value': '18.2', 'spread': '39.45', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 6 months', 'description': 'Contrast echocardiography was used to determine LVESV. Decreases in LVESV are associated with reduced mortality. Changes from baseline with positive values indicate a worsening in heart function and changes from baseline with negative values indicate an improvement in symptoms.', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Phase 2: Change in Absolute Left Ventricular End Systolic Volume (LVESV) From Baseline to Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MYDICAR® Low Dose', 'description': 'Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \\[AAV1\\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.'}, {'id': 'OG001', 'title': 'MYDICAR® Mid Dose', 'description': 'Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \\[AAV1\\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.'}, {'id': 'OG002', 'title': 'MYDICAR® High Dose', 'description': 'Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \\[AAV1\\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Single dose of placebo administered by antegrade epicardial coronary artery infusion.'}], 'classes': [{'categories': [{'measurements': [{'value': '40.7', 'spread': '59.79', 'groupId': 'OG000'}, {'value': '66.8', 'spread': '103.12', 'groupId': 'OG001'}, {'value': '9.9', 'spread': '49.27', 'groupId': 'OG002'}, {'value': '37.7', 'spread': '69.09', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 12 months', 'description': 'Contrast echocardiography was used to determine LVESV. Decreases in LVESV are associated with reduced mortality. Changes from baseline with positive values indicate a worsening in heart function and changes from baseline with negative values indicate an improvement in symptoms.', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Phase 1 and Phase 2: All Subject Deaths Through 36 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '37', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'MYDICAR® Very Low Dose', 'description': 'Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \\[AAV1\\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1.4E11 DRP administered by antegrade epicardial coronary artery infusion.'}, {'id': 'OG001', 'title': 'MYDICAR® Low Dose', 'description': 'Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \\[AAV1\\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.'}, {'id': 'OG002', 'title': 'MYDICAR® Mid Dose', 'description': 'Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \\[AAV1\\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.'}, {'id': 'OG003', 'title': 'MYDICAR® High Dose', 'description': 'Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \\[AAV1\\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.'}, {'id': 'OG004', 'title': 'All MYDICAR®', 'description': 'All participants who received a single infusion of MYDICAR® at any dose during the Phase 1 or Phase 2 studies.'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Single dose of placebo administered by antegrade epicardial coronary artery infusion.'}], 'classes': [{'title': 'Deaths within 12 months', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}]}, {'title': 'Deaths after 12 months', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}]}, {'title': 'Cardiovascular deaths on study', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'Cardiovascular deaths in long-term follow-up', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}]}, {'title': 'All deaths during 36 months', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '36 months', 'description': 'All subject deaths that occurred during the 12-month study or the 24-month follow-up in subjects enrolled in either the Phase 1 or Phase 2 trial. Events occurring after early termination from the trial are listed as occurring during long-term follow-up, but may have been within 12 months. Specifically, two cardiovascular (CV) deaths in placebo subjects occurred following early study termination, but within 12 months of study initiation. These deaths are therefore included under "Deaths within 12 months" but also listed as "Cardiovascular deaths in long-term follow-up." Accordingly, the number of "Cardiovascular deaths in long-term follow-up" for the placebo group is greater than the number of "Deaths after 12 months," as 2 of the deaths occurred within 12 months but after early termination.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes all participants enrolled in the Phase 1 or Phase 2 trial. Events occurring after early termination are listed under long-term follow-up. The number of "CV deaths in long-term follow-up" for the placebo group is greater than the number of "Deaths after 12 months," as 2 deaths occurred within 12 months but after early termination.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MYDICAR® Very Low Dose', 'description': 'Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \\[AAV1\\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1.4E11 DNAase resistant particles (DRP) administered by antegrade epicardial coronary artery infusion.\n\nThis arm was included only in the Phase I open-label dose-escalation period.'}, {'id': 'FG001', 'title': 'MYDICAR® Low Dose', 'description': 'Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \\[AAV1\\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DNAase resistant particles (DRP) administered by antegrade epicardial coronary artery infusion.'}, {'id': 'FG002', 'title': 'MYDICAR® Mid Dose', 'description': 'Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \\[AAV1\\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DNAase resistant particles (DRP) administered by antegrade epicardial coronary artery infusion.'}, {'id': 'FG003', 'title': 'MYDICAR® High Dose', 'description': 'Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \\[AAV1\\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DNAase resistant particles (DRP) administered by antegrade epicardial coronary artery infusion.'}, {'id': 'FG004', 'title': 'Placebo', 'description': 'Single dose of placebo administered by antegrade epicardial coronary artery infusion.\n\nThe placebo arm was included only in the Phase 2 randomized double-blind period.'}], 'periods': [{'title': 'Phase I: Open-label Dose-escalation', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Received heart transplant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Received left ventricular assist device', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}, {'title': 'Phase 2: Randomized Double-blind', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Received milrinone or dobutamine', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Received a heart transplant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Received left ventricular assist device', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}, {'value': '9', 'groupId': 'BG006'}, {'value': '14', 'groupId': 'BG007'}, {'value': '51', 'groupId': 'BG008'}]}], 'groups': [{'id': 'BG000', 'title': 'Phase 1: MYDICAR® Very Low Dose', 'description': 'Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \\[AAV1\\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1.4E11 DRP administered by antegrade epicardial coronary artery infusion.'}, {'id': 'BG001', 'title': 'Phase 1: MYDICAR® Low Dose', 'description': 'Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \\[AAV1\\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.'}, {'id': 'BG002', 'title': 'Phase 1: MYDICAR® Mid Dose', 'description': 'Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \\[AAV1\\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.'}, {'id': 'BG003', 'title': 'Phase 1: MYDICAR® High Dose', 'description': 'Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \\[AAV1\\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.'}, {'id': 'BG004', 'title': 'Phase 2: MYDICAR® Low Dose', 'description': 'Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \\[AAV1\\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.'}, {'id': 'BG005', 'title': 'Phase 2: MYDICAR® Mid Dose', 'description': 'Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \\[AAV1\\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.'}, {'id': 'BG006', 'title': 'Phase 2: MYDICAR® High Dose', 'description': 'Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 \\[AAV1\\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.'}, {'id': 'BG007', 'title': 'Phase 2: Placebo', 'description': 'Single dose of placebo administered by antegrade epicardial coronary artery infusion.'}, {'id': 'BG008', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.7', 'spread': '7.02', 'groupId': 'BG000'}, {'value': '55.7', 'spread': '4.51', 'groupId': 'BG001'}, {'value': '48.0', 'spread': '8.54', 'groupId': 'BG002'}, {'value': '58.77', 'spread': '19.01', 'groupId': 'BG003'}, {'value': '60.3', 'spread': '10.27', 'groupId': 'BG004'}, {'value': '63.9', 'spread': '8.85', 'groupId': 'BG005'}, {'value': '56.6', 'spread': '13.96', 'groupId': 'BG006'}, {'value': '61.0', 'spread': '11.94', 'groupId': 'BG007'}, {'value': '60.5', 'spread': '11.39', 'groupId': 'BG008'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '8', 'groupId': 'BG008'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '13', 'groupId': 'BG007'}, {'value': '43', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '6', 'groupId': 'BG008'}]}, {'title': 'White', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '13', 'groupId': 'BG007'}, {'value': '45', 'groupId': 'BG008'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Baseline data are provided for subjects enrolled in the Phase 1 or Phase 2 trials.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-19', 'studyFirstSubmitDate': '2007-03-30', 'resultsFirstSubmitDate': '2014-06-25', 'studyFirstSubmitQcDate': '2007-03-30', 'lastUpdatePostDateStruct': {'date': '2014-08-20', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-08-19', 'studyFirstPostDateStruct': {'date': '2007-04-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-08-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Phase 2: Length of Cardiovascular-related Hospitalizations at 12 Months', 'timeFrame': '12 months', 'description': 'Mean number of days in the hospital for cardiovascular-related complications. All hospitalizations were evaluated and classified by the blinded Clinical Endpoints Committee.'}, {'measure': 'Phase 2: Change in Symptomatic Efficacy Domains From Baseline to Month 12: New York Heart Association (NYHA) Class and Minnesota Living With Heart Failure Questionnaire (MLWHFQ) Score', 'timeFrame': 'Baseline to 12 months', 'description': 'NYHA classification is a symptomatic assessment in which the investigator evaluates subjects on a scale ranging from Class I (subjects with no limitation of activities, no symptoms from ordinary activities) to Class IV (subjects who should be at complete rest, confined to bed or chair; any physical activity brings on discomfort and symptoms occur at rest).\n\nThe MLWHFQ is a patient-reported quality of life (QoL) measure in which patients assess the impact of their heart condition on activities in the past month using a Likert scale ranging from 0 (no effect) to 5 (very much effect). Higher scores thus indicate a lower QoL. The maximum (worst) score is 105 and the minimum (best) score is 0.\n\nFor both measures, changes from baseline with positive values indicate a worsening in symptoms and changes from baseline with negative values indicate an improvement in symptoms.'}, {'measure': 'Phase 2: Change in 6-minute Walk Test (6MWT) From Baseline to Month 12', 'timeFrame': 'Baseline to 12 months', 'description': 'The 6MWT measures the distance walked in meters during a 6-minute test. Higher values indicate a better functional status. Changes from baseline with negative values indicate a worsening in function and changes from baseline with positive values indicate an improvement in function.'}, {'measure': 'Phase 2: Change in Peak Maximum Oxygen Consumption (VO2) From Baseline to Month 12', 'timeFrame': 'Baseline to 12 months', 'description': 'Peak VO2 is a measure of maximal oxygen consumption during cardiopulmonary exercise testing; this study used the modified Naughton treadmill protocol. Higher values indicate a better functional status. Changes from baseline with negative values indicate a worsening in function and changes from baseline with positive values indicate an improvement in function.'}, {'measure': 'Phase 2: Change in Absolute Levels of N-terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) From Baseline to Month 12', 'timeFrame': 'Baseline to 12 months', 'description': 'NT-proBNP is a biomarker for heart failure. Increased levels of this biomarker are associated with increased mortality and cardiovascular hospitalization in patients with heart failure.'}, {'measure': 'Phase 2: Change in Percentage of Blood Ejected From the Left Ventricle (LV) (i.e., Left Ventricular Ejection Fraction [LVEF]) From Baseline to Month 12', 'timeFrame': 'Baseline to 12 months', 'description': 'Contrast echocardiography was used to determine LVEF. Increases in LVEF are associated with reduced mortality. Changes from baseline with positive values indicate an improvement in heart function and changes from baseline with negative values indicate a worsening of heart function.'}, {'measure': 'Phase 2: Change in Absolute Left Ventricular End Systolic Volume (LVESV) From Baseline to Month 12', 'timeFrame': 'Baseline to 12 months', 'description': 'Contrast echocardiography was used to determine LVESV. Decreases in LVESV are associated with reduced mortality. Changes from baseline with positive values indicate a worsening in heart function and changes from baseline with negative values indicate an improvement in symptoms.'}, {'measure': 'Phase 1 and Phase 2: All Subject Deaths Through 36 Months', 'timeFrame': '36 months', 'description': 'All subject deaths that occurred during the 12-month study or the 24-month follow-up in subjects enrolled in either the Phase 1 or Phase 2 trial. Events occurring after early termination from the trial are listed as occurring during long-term follow-up, but may have been within 12 months. Specifically, two cardiovascular (CV) deaths in placebo subjects occurred following early study termination, but within 12 months of study initiation. These deaths are therefore included under "Deaths within 12 months" but also listed as "Cardiovascular deaths in long-term follow-up." Accordingly, the number of "Cardiovascular deaths in long-term follow-up" for the placebo group is greater than the number of "Deaths after 12 months," as 2 of the deaths occurred within 12 months but after early termination.'}], 'primaryOutcomes': [{'measure': 'Phase 2: Incidence of Treatment-emergent Adverse Events (TEAE) at 12 Months', 'timeFrame': '12 months', 'description': 'Includes all adverse events that occurred from the time of first infusion of the investigational product or placebo to the 12-month visit. The category of "TEAEs related to the investigational product (IP)" includes TEAEs considered by the investigator to be possibly, probably, or definitely related to the IP.'}, {'measure': 'Phase 2: Length of Cardiovascular-related Hospitalizations at 6 Months', 'timeFrame': '6 months', 'description': 'Mean number of days in the hospital for cardiovascular-related complications. All hospitalizations were evaluated and classified by the blinded Clinical Endpoints Committee.'}, {'measure': 'Phase 2: Change in Symptomatic Efficacy Domains From Baseline to Month 6: New York Heart Association (NYHA) Class and Minnesota Living With Heart Failure Questionnaire (MLWHFQ) Score', 'timeFrame': 'Baseline to 6 months', 'description': 'NYHA classification is a symptomatic assessment in which the investigator evaluates subjects on a scale ranging from Class I (subjects with no limitation of activities, no symptoms from ordinary activities) to Class IV (subjects who should be at complete rest, confined to bed or chair; any physical activity brings on discomfort and symptoms occur at rest).\n\nThe MLWHFQ is a patient-reported quality of life (QoL) measure in which patients assess the impact of their heart condition on activities in the past month using a Likert scale ranging from 0 (no effect) to 5 (very much effect). Higher scores thus indicate a lower QoL. The maximum (worst) score is 105 and the minimum (best) score is 0.\n\nFor both measures, changes from baseline with positive values indicate a worsening in symptoms and changes from baseline with negative values indicate an improvement in symptoms.'}, {'measure': 'Phase 2: Change in 6-minute Walk Test (6MWT) From Baseline to Month 6', 'timeFrame': 'Baseline to 6 months', 'description': 'The 6MWT measures the distance walked in meters during a 6-minute test. Higher values indicate a better functional status. Changes from baseline with negative values indicate a worsening in function and changes from baseline with positive values indicate an improvement in function.'}, {'measure': 'Phase 2: Change in Peak Maximum Oxygen Consumption (VO2) From Baseline to Month 6', 'timeFrame': 'Baseline to 6 months', 'description': 'Peak VO2 is a measure of maximal oxygen consumption during cardiopulmonary exercise testing; this study used the modified Naughton treadmill protocol. Higher values indicate a better functional status. Changes from baseline with negative values indicate a worsening in function and changes from baseline with positive values indicate an improvement in function.'}, {'measure': 'Phase 2: Change in Absolute Levels of N-terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) From Baseline to Month 6', 'timeFrame': 'Baseline to 6 months', 'description': 'NT-proBNP is a biomarker for heart failure. Increased levels of this biomarker are associated with increased mortality and cardiovascular hospitalization in patients with heart failure.'}, {'measure': 'Phase 2: Change in Percentage of Blood Ejected From the Left Ventricle (LV) (i.e., Left Ventricular Ejection Fraction [LVEF]) From Baseline to Month 6', 'timeFrame': 'Baseline to 6 months', 'description': 'Contrast echocardiography was used to determine LVEF. Increases in LVEF are associated with reduced mortality. Changes from baseline with positive values indicate an improvement in heart function and changes from baseline with negative values indicate a worsening of heart function.'}, {'measure': 'Phase 2: Change in Absolute Left Ventricular End Systolic Volume (LVESV) Frm Baseline to Month 6', 'timeFrame': 'Baseline to 6 months', 'description': 'Contrast echocardiography was used to determine LVESV. Decreases in LVESV are associated with reduced mortality. Changes from baseline with positive values indicate a worsening in heart function and changes from baseline with negative values indicate an improvement in symptoms.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Heart Failure, Congestive', 'Dilated Cardiomyopathy']}, 'referencesModule': {'references': [{'pmid': '21340529', 'type': 'BACKGROUND', 'citation': 'Horowitz JD, Rosenson RS, McMurray JJ, Marx N, Remme WJ. Clinical Trials Update AHA Congress 2010. Cardiovasc Drugs Ther. 2011 Feb;25(1):69-76. doi: 10.1007/s10557-011-6285-9.'}, {'pmid': '18514926', 'type': 'BACKGROUND', 'citation': 'Hajjar RJ, Zsebo K, Deckelbaum L, Thompson C, Rudy J, Yaroshinsky A, Ly H, Kawase Y, Wagner K, Borow K, Jaski B, London B, Greenberg B, Pauly DF, Patten R, Starling R, Mancini D, Jessup M. Design of a phase 1/2 trial of intracoronary administration of AAV1/SERCA2a in patients with heart failure. J Card Fail. 2008 Jun;14(5):355-67. doi: 10.1016/j.cardfail.2008.02.005. Epub 2008 May 27.'}, {'pmid': '19327618', 'type': 'RESULT', 'citation': 'Jaski BE, Jessup ML, Mancini DM, Cappola TP, Pauly DF, Greenberg B, Borow K, Dittrich H, Zsebo KM, Hajjar RJ; Calcium Up-Regulation by Percutaneous Administration of Gene Therapy In Cardiac Disease (CUPID) Trial Investigators. Calcium upregulation by percutaneous administration of gene therapy in cardiac disease (CUPID Trial), a first-in-human phase 1/2 clinical trial. J Card Fail. 2009 Apr;15(3):171-81. doi: 10.1016/j.cardfail.2009.01.013.'}, {'pmid': '21709064', 'type': 'RESULT', 'citation': 'Jessup M, Greenberg B, Mancini D, Cappola T, Pauly DF, Jaski B, Yaroshinsky A, Zsebo KM, Dittrich H, Hajjar RJ; Calcium Upregulation by Percutaneous Administration of Gene Therapy in Cardiac Disease (CUPID) Investigators. Calcium Upregulation by Percutaneous Administration of Gene Therapy in Cardiac Disease (CUPID): a phase 2 trial of intracoronary gene therapy of sarcoplasmic reticulum Ca2+-ATPase in patients with advanced heart failure. Circulation. 2011 Jul 19;124(3):304-13. doi: 10.1161/CIRCULATIONAHA.111.022889. Epub 2011 Jun 27.'}, {'pmid': '24065463', 'type': 'RESULT', 'citation': 'Zsebo K, Yaroshinsky A, Rudy JJ, Wagner K, Greenberg B, Jessup M, Hajjar RJ. Long-term effects of AAV1/SERCA2a gene transfer in patients with severe heart failure: analysis of recurrent cardiovascular events and mortality. Circ Res. 2014 Jan 3;114(1):101-8. doi: 10.1161/CIRCRESAHA.113.302421. Epub 2013 Sep 24.'}]}, 'descriptionModule': {'briefSummary': 'The study is divided into 2 parts. In the first part, the safety of the gene transfer agent MYDICAR® will be evaluated. In the second part, the ability of MYDICAR® to improve heart function will be studied.', 'detailedDescription': 'The American Heart Association (AHA) 2006 update on heart disease reported that 5 million Americans are believed to have symptomatic heart failure (HF), and 550,000 patients are newly diagnosed each year. The estimated direct and indirect cost of HF in the United States (U.S.) for 2006 will be \\~$29.6 billion. Heart failure is a disabling chronic disease and the most frequent discharge diagnosis for hospitalization among older adults. Despite the significant resources expended on the treatment of this disease, outcomes remain poor. The five-year survival for individuals diagnosed with heart failure is less than 50%, and in end-stage heart failure, the one-year survival may be as low as 25% regardless of medical therapy.\n\nRecent studies suggest that the failing heart is not refractory to treatment, as was previously believed. For example, the observation that a small percentage of subjects with left ventricular assist devices (LVADs) can be permanently weaned from their device strongly suggests that damaged hearts are capable of recovering lost function.\n\nClinical studies of MYDICAR® have not yet been conducted in humans. Celladon Corporation (Celladon) proposes to investigate gene transfer as a method to restore SERCA2a function in heart failure (HF) patients using a recombinant adeno-associated viral vector (AAV), which consists of an AAV serotype 1 capsid and contains the human SERCA2a complementary DNA (cDNA) flanked by Inverted Terminal Repeats (ITR) derived from AAV serotype 2 (AAV1/SERCA2a). MYDICAR® refers to AAV1/SERCA2a drug product intended for administration by percutaneous delivery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Chronic ischemic or non-ischemic cardiomyopathy. Subjects with ischemic cardiomyopathy must have at least one major coronary vessel with Thrombolysis in Myocardial Infarction (TIMI) grade 3 flow.\n* Left ventricular ejection fraction (LVEF) ≤35%\n* Diagnosis of New York Heart Association (NYHA) Class III/IV heart failure for a minimum of 3 months prior to screening\n* Maximal oxygen consumption (VO2 max) ≤20 mL/kg/min within 90 days prior to enrollment\n* An implantable cardioverter defibrillator (ICD) implanted a minimum of 30 days prior to enrollment\n* Treatment with appropriate heart failure therapy as tolerated\n* All women of childbearing potential must have a negative urine pregnancy test prior to administration of investigational product and agree to use adequate contraception. Men capable of fathering a child must agree to use barrier contraception or limit activity to post-menopausal, surgically sterilized, or a contraception-practicing partner, for 3 months after administration of investigational product.\n* Ability to sign Informed Consent Form (ICF) and Release of Medical Information Form\n\nExclusion Criteria:\n\n* Any intravenous therapy with positive inotropes, vasodilators, or diuretics within 30 days prior to enrollment\n* Restrictive cardiomyopathy, obstructive cardiomyopathy, pericardial disease, amyloidosis, infiltrative cardiomyopathy, uncorrected thyroid disease, or dyskinetic LV aneurysm\n* Cardiac surgery, percutaneous coronary intervention, or valvuloplasty within 30 days prior to enrollment\n* Clinically significant myocardial infarction (e.g., ST elevation MI \\[STEMI\\] or large non-STEMI) within 6 months prior to enrollment\n* Prior heart transplantation, left ventricular reduction surgery (LVRS), cardiomyoplasty, passive restraint device (e.g., CorCap™ Cardiac Support Device), surgically implanted LVAD or cardiac shunt\n* Likely to receive cardiac resynchronization therapy, cardiomyoplasty, LVRS, heart transplant, conventional revascularization procedure, or valvular repair within 6 months following enrollment\n* Patients with prior coronary artery bypass graft(s) (CABG) will reviewed on a case-by-case basis\n* No evidence of functional or viable myocardium\n* Exercise capacity primarily limited by obesity, peripheral vascular disease, intrinsic pulmonary disease or orthopedic problems and not by underlying heart failure\n* Known hypersensitivity to octafluoropropane (component of the intravenous echocardiography contrast agent, DEFINITY®) or other contrast dyes used for angiography; history of, or likely need for, high dose steroid pretreatment prior to contrast angiography\n* A left ventricle that is difficult to image or high quality echocardiography is not obtainable at screening\n* Significant left main or ostial right coronary lumenal stenosis in the opinion of the investigator\n* Expected survival \\<1 year in the investigator's medical opinion\n* Suspected or active viral, bacterial, fungal, or parasitic infection within 48 hours prior to enrollment\n* Liver function tests (alanine aminotransferase \\[ALT\\], aspartate aminotransferase \\[AST\\], alkaline phosphatase) \\>2x Upper Limit of Normal (ULN) within 30 days prior to enrollment or known intrinsic liver disease (e.g., cirrhosis, chronic hepatitis B or hepatitis C virus infection)\n* Current or likely need for hemodialysis within 12 months following enrollment\n* Bleeding diathesis or thrombocytopenia defined as platelet count \\<50,000 platelets/μL\n* Anemia defined as hemoglobin \\<10 g/dL\n* Known AIDS or HIV-positive status, or a previous diagnosis of immunodeficiency with an absolute neutrophil count \\<1000 cells/mm3\n* Previous participation in a study of gene transfer\n* Presence of neutralizing anti-AAV1 antibodies at titer ≥1:2 within 3 months of screening\n* Receiving investigational intervention or participating in another clinical study within 30 days or within 5 half-lives of the investigational drug administration prior to enrollment\n* Pregnancy or lactation\n* Recent history of psychiatric disease (including drug or alcohol abuse) that is likely to impair subject's ability to comply with protocol-mandated procedures, in the opinion of the investigator\n* Other concurrent medical condition(s) that, while not explicitly excluded by the protocol, could jeopardize the safety of the patient or objectives of the study"}, 'identificationModule': {'nctId': 'NCT00454818', 'acronym': 'CUPID', 'briefTitle': 'Efficacy and Safety Study of Genetically Targeted Enzyme Replacement Therapy for Advanced Heart Failure', 'organization': {'class': 'INDUSTRY', 'fullName': 'Celladon Corporation'}, 'officialTitle': 'A Phase 1/2 Trial of Intracoronary Administration of MYDICAR® (AAV1/SERCA2a) in Subjects With Heart Failure in Two Stages (Open-Label, Sequential Dose-Escalation Cohorts and Randomized, Double-Blind, Placebo-Controlled, Parallel Cohorts)', 'orgStudyIdInfo': {'id': 'CELL-001'}, 'secondaryIdInfos': [{'id': 'CUPID Trial', 'type': 'REGISTRY', 'domain': 'NCT00454818'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MYDICAR Very Low Dose', 'description': 'Single dose of MYDICAR, a viral vector (adeno-associated virus serotype 1 \\[AAV1\\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1.4x10e11 DNAase resistant particles administered by antegrade epicardial coronary artery infusion. Used in MYDICAR Phase 1 (Open-label, Serial Dose-Escalation Study) only.', 'interventionNames': ['Genetic: MYDICAR Phase 1 (Open-label, Serial Dose-Escalation Study)']}, {'type': 'EXPERIMENTAL', 'label': 'MYDICAR Low Dose', 'description': 'Single dose of MYDICAR, a viral vector (adeno-associated virus serotype 1 \\[AAV1\\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6x10e11 DNAase resistant particles administered by antegrade epicardial coronary artery infusion. Used in MYDICAR Phase 1 (Open-label, Serial Dose-Escalation Study) and MYDICAR Phase 2 (Placebo-controlled, Randomized Study)', 'interventionNames': ['Genetic: MYDICAR Phase 1 (Open-label, Serial Dose-Escalation Study)', 'Genetic: MYDICAR Phase 2 (Placebo-controlled, Randomized Study)']}, {'type': 'EXPERIMENTAL', 'label': 'MYDICAR Mid Dose', 'description': 'Single dose of MYDICAR, a viral vector (adeno-associated virus serotype 1 \\[AAV1\\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3x10e12 DNAase resistant particles administered by antegrade epicardial coronary artery infusion. Used in MYDICAR Phase 1 (Open-label, Serial Dose-Escalation Study) and MYDICAR Phase 2 (Placebo-controlled, Randomized Study).', 'interventionNames': ['Genetic: MYDICAR Phase 1 (Open-label, Serial Dose-Escalation Study)', 'Genetic: MYDICAR Phase 2 (Placebo-controlled, Randomized Study)']}, {'type': 'EXPERIMENTAL', 'label': 'MYDICAR High Dose', 'description': 'Single dose of MYDICAR, a viral vector (adeno-associated virus serotype 1 \\[AAV1\\]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1x10e13 DNAase resistant particles administered by antegrade epicardial coronary artery infusion. Used in MYDICAR Phase 1 (Open-label, Serial Dose-Escalation Study) and MYDICAR Phase 2 (Placebo-controlled, Randomized Study).', 'interventionNames': ['Genetic: MYDICAR Phase 1 (Open-label, Serial Dose-Escalation Study)', 'Genetic: MYDICAR Phase 2 (Placebo-controlled, Randomized Study)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo infusion', 'description': 'A single dose of placebo (Sodium Chloride Injection, USP) administered by antegrade epicardial coronary artery infusion.', 'interventionNames': ['Procedure: Placebo Infusion']}], 'interventions': [{'name': 'MYDICAR Phase 1 (Open-label, Serial Dose-Escalation Study)', 'type': 'GENETIC', 'otherNames': ['AAV1/SERCA2a'], 'description': 'MYDICAR administered by antegrade epicardial coronary artery infusion', 'armGroupLabels': ['MYDICAR High Dose', 'MYDICAR Low Dose', 'MYDICAR Mid Dose', 'MYDICAR Very Low Dose']}, {'name': 'Placebo Infusion', 'type': 'PROCEDURE', 'description': 'Saline; epicardial coronary artery infusion', 'armGroupLabels': ['Placebo infusion']}, {'name': 'MYDICAR Phase 2 (Placebo-controlled, Randomized Study)', 'type': 'GENETIC', 'otherNames': ['AAV1/SERCA2a'], 'description': 'MYDICAR administered by antegrade epicardial coronary artery infusion', 'armGroupLabels': ['MYDICAR High Dose', 'MYDICAR Low Dose', 'MYDICAR Mid Dose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'University of California at San Diego Medical Center', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'San Diego Cardiac Center', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '32608', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'Shands Hospital at University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '64111', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': "Mid America Heart Institute, Saint Luke's Hospital", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'St. Louis University Hospital', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '07101', 'city': 'Newark', 'state': 'New Jersey', 'country': 'United States', 'facility': 'University of Medicine and Dentistry of New Jersey', 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount Sinai Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '45267', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'University of Cincinnati', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44109', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'MetroHealth Medical Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic Foundation', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health and Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Hospital of the University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Medical Center, Presbyterian-Shadyside Hospital', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '37388', 'city': 'Tullahoma', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Tennessee Center for Clinical Trials & Harton Regional Medical Center', 'geoPoint': {'lat': 35.36202, 'lon': -86.20943}}, {'zip': '75230', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Cardiopulmonary Research Science and Technology Institute, Medical City Dallas Hospital', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Methodist Hospital', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84157', 'city': 'Murray', 'state': 'Utah', 'country': 'United States', 'facility': 'Intermountain Medical Center', 'geoPoint': {'lat': 40.66689, 'lon': -111.88799}}, {'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Brian Jaski, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'San Diego Cardiac Center'}, {'name': 'Donna Mancini, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University Hospital'}, {'name': 'Randall Starling, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Cleveland Clinic'}, {'name': 'Mariell Jessup, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Pennsylvania'}, {'name': 'Thomas Cappola, MD, ScM', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}, {'name': 'Daniel Pauly, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shands Hospital, University of Florida at Gainesville'}, {'name': 'Barry London, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh Medical Center'}, {'name': 'Barry Greenberg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California at San Diego Medical Center'}, {'name': 'A. G. Kfoury, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Intermountain Medical Center'}, {'name': 'Stephen Archer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Chicago'}, {'name': 'Andrew Kao, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Mid America Heart Institute, Saint Luke's Hospital"}, {'name': 'Paul J. Hauptman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St. Louis University Hospital'}, {'name': 'Jill Kalman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Icahn School of Medicine at Mount Sinai'}, {'name': 'Douglas W. Losordo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwestern University'}, {'name': 'Eric J. Eichhorn, MD, FACC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cardiopulmonary Research Science and Technology Institutte, Medical City Dallas Hospital'}, {'name': 'Stephanie H. Dunlap, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Cincinnati'}, {'name': 'Vinay Thohan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University'}, {'name': 'Maryl R. Johnson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wisconsin, Madison'}, {'name': 'Mark Dunlap, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MetroHealth Medical Center'}, {'name': 'Joaquin E. Cigarroa, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oregon Health and Science University'}, {'name': 'Dinesh K. Gupta, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tennessee Center for Clinical Trials, Harton Regional Medical Center'}, {'name': 'Marc Klapholz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Medicine and Dentistry of New Jersey'}, {'name': 'Guillermo Torre, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Methodist Hospital Research Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Celladon Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}