Viewing Study NCT02874794

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Ignite Creation Date: 2025-12-25 @ 1:47 AM
Ignite Modification Date: 2026-02-25 @ 8:18 PM
Study NCT ID: NCT02874794
Status: COMPLETED
Last Update Posted: 2021-01-05
First Post: 2016-08-05
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Study of Effects of Sacubitril/Valsartan vs. Enalapril on Aortic Stiffness in Patients With Mild to Moderate HF With Reduced Ejection Fraction
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': 'D054143', 'term': 'Heart Failure, Systolic'}, {'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C549068', 'term': 'sacubitril and valsartan sodium hydrate drug combination'}, {'id': 'C000717211', 'term': 'sacubitril'}, {'id': 'D000068756', 'term': 'Valsartan'}, {'id': 'D004656', 'term': 'Enalapril'}], 'ancestors': [{'id': 'D013777', 'term': 'Tetrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D014633', 'term': 'Valine'}, {'id': 'D000597', 'term': 'Amino Acids, Branched-Chain'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000601', 'term': 'Amino Acids, Essential'}, {'id': 'D004151', 'term': 'Dipeptides'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D010455', 'term': 'Peptides'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Novartis.email@novartis.com', 'phone': '862-778-8300', 'title': 'Study Director', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 2.5 years.', 'description': 'Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Double Blind Phase Enalapril', 'description': 'Minimum dose: 2.5mg, BID, oral, tablet. Maximum dose: 10 mg, BID, oral tablet. All patients began on Dose Level 1 (2.5mg) and were titrated every two weeks to target Dose level 3 (10mg).', 'otherNumAtRisk': 233, 'deathsNumAtRisk': 233, 'otherNumAffected': 32, 'seriousNumAtRisk': 233, 'deathsNumAffected': 1, 'seriousNumAffected': 21}, {'id': 'EG001', 'title': 'Double Blind Phase Sacubitril/Valsartan', 'description': 'Minimum dose: 24/26mg, BID, oral, tablet. Maximum dose:\n\n97/103mg, BID, oral, tablet. All patients began on Dose Level 1 (24/26mg) and were titrated every two weeks to target Dose level 3 (97/103mg).', 'otherNumAtRisk': 231, 'deathsNumAtRisk': 231, 'otherNumAffected': 43, 'seriousNumAtRisk': 231, 'deathsNumAffected': 1, 'seriousNumAffected': 17}, {'id': 'EG002', 'title': 'Open-Label Phase Sacubitril/Valsartan', 'description': 'LCZ696 tablets were provided for the 12-week open label extension.', 'otherNumAtRisk': 454, 'deathsNumAtRisk': 454, 'otherNumAffected': 42, 'seriousNumAtRisk': 454, 'deathsNumAffected': 5, 'seriousNumAffected': 40}], 'otherEvents': [{'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 454, 'numAffected': 12}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 454, 'numAffected': 15}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 454, 'numAffected': 16}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 454, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 454, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Acute left ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 454, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 454, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 454, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 454, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 454, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Atrioventricular block complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 454, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 454, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 454, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 454, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Cardiac failure chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 454, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 454, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Cardiomegaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 454, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Cardiovascular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 454, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 454, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Left ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 454, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 454, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Ventricular fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 454, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 454, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 454, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 454, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Multiple organ dysfunction syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 454, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 454, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 454, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 454, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 454, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 454, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 454, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Abdominal wall abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 454, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 454, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 454, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Device related sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 454, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 454, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 454, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Periorbital cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 454, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 454, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 454, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 454, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 454, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 454, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 454, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 454, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Troponin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 454, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 454, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 454, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 454, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 454, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 454, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 454, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 454, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Hepatic cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 454, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Myelodysplastic syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 454, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Plasma cell myeloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}, 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All patients began on Dose Level 1 (2.5mg) and were titrated every two weeks to target Dose level 3 (10mg).'}, {'id': 'OG001', 'title': 'Sacubitril/Valsartan (Double-Blind Phase)', 'description': 'minimum dose: 24/26mg, BID, oral, tablet. maximum dose: 97/103mg, BID, oral, tablet. All patients began on Dose Level 1 (24/26mg) and were titrated every two weeks to target Dose level 3 (97/103mg).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.03', 'spread': '0.01', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '0.02', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8215', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.00', 'ciLowerLimit': '-0.05', 'ciUpperLimit': '0.04', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'Parameter measured by echocardiography', 'unitOfMeasure': 'Ea/Ees Ratio', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Echocardiographic Measure: Left Ventricular End Systolic Volume Index (LVESVi)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enalapril (Double-Blind Phase)', 'description': 'minimum dose: 2.5mg, BID, oral, tablet. maximum dose: 10 mg, BID, oral tablet. All patients began on Dose Level 1 (2.5mg) and were titrated every two weeks to target Dose level 3 (10mg).'}, {'id': 'OG001', 'title': 'Sacubitril/Valsartan (Double-Blind Phase)', 'description': 'minimum dose: 24/26mg, BID, oral, tablet. maximum dose: 97/103mg, BID, oral, tablet. All patients began on Dose Level 1 (24/26mg) and were titrated every two weeks to target Dose level 3 (97/103mg).'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.28', 'spread': '0.55', 'groupId': 'OG000'}, {'value': '-4.86', 'spread': '0.56', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0452', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.58', 'ciLowerLimit': '-3.13', 'ciUpperLimit': '-0.03', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'Parameter measured by echocardiography', 'unitOfMeasure': 'mL/m2', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Echocardiographic Measure: Left Ventricular End Diastolic Volume Index (LVEDVi)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enalapril (Double-Blind Phase)', 'description': 'minimum dose: 2.5mg, BID, oral, tablet. maximum dose: 10 mg, BID, oral tablet. All patients began on Dose Level 1 (2.5mg) and were titrated every two weeks to target Dose level 3 (10mg).'}, {'id': 'OG001', 'title': 'Sacubitril/Valsartan (Double-Blind Phase)', 'description': 'minimum dose: 24/26mg, BID, oral, tablet. maximum dose: 97/103mg, BID, oral, tablet. All patients began on Dose Level 1 (24/26mg) and were titrated every two weeks to target Dose level 3 (97/103mg).'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.18', 'spread': '0.61', 'groupId': 'OG000'}, {'value': '-5.15', 'spread': '0.62', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0242', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.97', 'ciLowerLimit': '-3.68', 'ciUpperLimit': '-0.26', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'Parameter measured by echocardiography', 'unitOfMeasure': 'mL/m2', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Enalapril (Double-Blind Phase)', 'description': 'minimum dose: 2.5mg, BID, oral, tablet. maximum dose: 10 mg, BID, oral tablet. All patients began on Dose Level 1 (2.5mg) and were titrated every two weeks to target Dose level 3 (10mg).'}, {'id': 'FG001', 'title': 'Sacubitril/Valsartan (Double-Blind Phase)', 'description': 'minimum dose: 24/26mg, BID, oral, tablet. maximum dose: 97/103mg, BID, oral, tablet. All patients began on Dose Level 1 (24/26mg) and were titrated every two weeks to target Dose level 3 (97/103mg).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '233'}, {'groupId': 'FG001', 'numSubjects': '232'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '226'}, {'groupId': 'FG001', 'numSubjects': '221'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Of 892 patients screened for the study, 465 completed screening and were enrolled. Of the 465 randomized, 1 patient was randomized in error to the sacubitril/valsartan group and was not treated. The Full Analysis Set and Safety Set are based on 464 patients who received treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'BG000'}, {'value': '231', 'groupId': 'BG001'}, {'value': '464', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Enalapril (Double-Blind Phase)', 'description': 'minimum dose: 2.5mg, BID, oral, tablet. maximum dose: 10 mg, BID, oral tablet. All patients began on Dose Level 1 (2.5mg) and were titrated every two weeks to target Dose level 3 (10mg).'}, {'id': 'BG001', 'title': 'Sacubitril/Valsartan (Double-Blind Phase)', 'description': 'minimum dose: 24/26mg, BID, oral, tablet. maximum dose: 97/103mg, BID, oral, tablet. All patients began on Dose Level 1 (24/26mg) and were titrated every two weeks to target Dose level 3 (97/103mg).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '100', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '190', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '133', 'groupId': 'BG000'}, {'value': '141', 'groupId': 'BG001'}, {'value': '274', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '185', 'groupId': 'BG000'}, {'value': '170', 'groupId': 'BG001'}, {'value': '355', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian (White)', 'categories': [{'measurements': [{'value': '175', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '341', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Native American', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'articipants'}], 'populationDescription': 'Full Analysis Set'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-03-15', 'size': 1022961, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-01-21T13:26', 'hasProtocol': True}, {'date': '2019-03-26', 'size': 605083, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-01-21T13:26', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 465}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'dispFirstSubmitDate': '2019-05-30', 'completionDateStruct': {'date': '2019-01-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-09', 'studyFirstSubmitDate': '2016-08-05', 'dispFirstSubmitQcDate': '2019-09-09', 'resultsFirstSubmitDate': '2020-01-21', 'studyFirstSubmitQcDate': '2016-08-17', 'dispFirstPostDateStruct': {'date': '2019-09-17', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-03-17', 'studyFirstPostDateStruct': {'date': '2016-08-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Aortic Characteristic Impedance at Week 12', 'timeFrame': 'Baseline, Week 12', 'description': 'Aortic characteristic impedance, Zc, is the ratio of the change in pressure (dP)produced by a given change in flow (dQ) in early systole, i.e., Zc = dP/dQ. Zc is related directly to aortic wall stiffness and inversely to lumen area.'}], 'secondaryOutcomes': [{'measure': 'Pearson Correlation Coefficient Between Change From Baseline in Aortic Characteristic Impedance and Biomarker Levels: B-type Natriuretic Peptide (BNP) During Both Trough and 4 Hours Post-dose at Week 4', 'timeFrame': 'Pre-dose and 4 hours post dose at week 4', 'description': 'Pearson correlation coefficients between changes from baseline in aortic characteristic impedance (dyne x sec/cm5) and biomarker levels such as BNP (pg/ML) during both trough and 4 hours post-dose at Week 4'}, {'measure': 'Pearson Correlation Coefficient Between Change From Baseline in Aortic Characteristic Impedance and Biomarker Levels: cGMP/U-creatinine During Both Trough and 4 Hours Post-dose at Week 4', 'timeFrame': 'pre-dose and 4 hours post dose at week 4', 'description': 'Pearson correlation coefficient between changes from baseline in aortic characteristic impedance (dyne x sec/cm5) and biomarker levels such as U-cGMP/U-creatinine ratio (nmol/mmol) during both trough and 4 hours post-dose at Week 4'}, {'measure': 'Change From Baseline in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)', 'timeFrame': 'Baseline, Week 12', 'description': 'Change from baseline in N-terminal pro-brain natriuretic peptide (NT-proBNP)'}, {'measure': 'Change From Baseline in Echocardiographic Measure: Global Longitudinal Strain', 'timeFrame': 'Baseline, Week 12', 'description': 'Parameter measured by echocardiography.'}, {'measure': 'Change From Baseline in Echocardiographic Measure: Left Atrial Volume Index (LAVi)', 'timeFrame': 'Baseline, Week 12', 'description': 'Parameter measured by echocardiography'}, {'measure': "Change From Baseline in Echocardiographic Measure: Mitral Annular E' Velocity (Doppler Tissue Imaging)", 'timeFrame': 'Baseline, Week 12', 'description': 'Parameter measured by echocardiography'}, {'measure': "Change From Basekine in Echocardiographic Measure: Mitral E/E'", 'timeFrame': 'Baseline, Week 12', 'description': 'Parameter measured by echocardiography'}, {'measure': 'Change From Baseline in Echocardiographic Measure: Left Ventricular Ejection Fraction (LVEF)', 'timeFrame': 'Baseline, Week 12', 'description': 'Parameter measured by echocardiography'}, {'measure': 'Change From Baseline in Echocardiographic Measure: Ventricular-vascular Coupling (Ea/Ees)', 'timeFrame': 'Baseline, Week 12', 'description': 'Parameter measured by echocardiography'}, {'measure': 'Change From Baseline in Echocardiographic Measure: Left Ventricular End Systolic Volume Index (LVESVi)', 'timeFrame': 'Baseline, Week 12', 'description': 'Parameter measured by echocardiography'}, {'measure': 'Change From Baseline in Echocardiographic Measure: Left Ventricular End Diastolic Volume Index (LVEDVi)', 'timeFrame': 'Baseline, Week 12', 'description': 'Parameter measured by echocardiography'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Heart Failure', 'Reduced Ejection Fraction', 'Central Aortic Stiffness', 'Vascular', 'Echocardiogram', 'Aortic Stiffness'], 'conditions': ['Heart Failure and Reduced Ejection Fraction']}, 'referencesModule': {'references': [{'pmid': '40678912', 'type': 'DERIVED', 'citation': 'Lee S, Claggett BL, Fang JC, Mitchell GF, Ward JH, Solomon SD, Skali H, Desai AS, Hegde SM. Changes in cardiac structure and function are associated with health-related quality of life in heart failure patients with reduced ejection fraction: Results from the EVALUATE-HF trial. Eur J Heart Fail. 2025 Jul 18. doi: 10.1002/ejhf.3760. Online ahead of print.'}, {'pmid': '35560696', 'type': 'DERIVED', 'citation': 'Myhre PL, Claggett BL, Shah AM, Prescott MF, Ward JH, Fang JC, Mitchell GF, Solomon SD, Desai AS. Changes in cardiac biomarkers in association with alterations in cardiac structure and function, and health status in heart failure with reduced ejection fraction: the EVALUATE-HF trial. Eur J Heart Fail. 2022 Jul;24(7):1200-1208. doi: 10.1002/ejhf.2541. Epub 2022 May 30.'}, {'pmid': '35115085', 'type': 'DERIVED', 'citation': 'Myhre PL, Prescott MF, Murphy SP, Fang JC, Mitchell GF, Ward JH, Claggett B, Desai AS, Solomon SD, Januzzi JL. Early B-Type Natriuretic Peptide Change in HFrEF Patients Treated With Sacubitril/Valsartan: A Pooled Analysis of EVALUATE-HF and PROVE-HF. JACC Heart Fail. 2022 Feb;10(2):119-128. doi: 10.1016/j.jchf.2021.09.007. Epub 2022 Jan 12.'}, {'pmid': '33663237', 'type': 'DERIVED', 'citation': 'Mitchell GF, Solomon SD, Shah AM, Claggett BL, Fang JC, Izzo J, Abbas CA, Desai AS; EVALUATE-HF Investigators*. Hemodynamic Effects of Sacubitril-Valsartan Versus Enalapril in Patients With Heart Failure in the EVALUATE-HF Study: Effect Modification by Left Ventricular Ejection Fraction and Sex. Circ Heart Fail. 2021 Mar;14(3):e007891. doi: 10.1161/CIRCHEARTFAILURE.120.007891. Epub 2021 Mar 5.'}, {'pmid': '31475296', 'type': 'DERIVED', 'citation': 'Desai AS, Solomon SD, Shah AM, Claggett BL, Fang JC, Izzo J, McCague K, Abbas CA, Rocha R, Mitchell GF; EVALUATE-HF Investigators. Effect of Sacubitril-Valsartan vs Enalapril on Aortic Stiffness in Patients With Heart Failure and Reduced Ejection Fraction: A Randomized Clinical Trial. JAMA. 2019 Sep 17;322(11):1077-1084. doi: 10.1001/jama.2019.12843.'}], 'seeAlsoLinks': [{'url': 'https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=514', 'label': 'A Plain Language Trial Summary is available on novartisclinicatrials.com'}]}, 'descriptionModule': {'briefSummary': 'To determine whether treatment with sacubitril/valsartan provides a superior effect on aortic characteristic impedance compared to enalapril in patients with heart failure and reduced ejection fraction (left ventricular ejection fraction \\[LVEF\\] ≤ 40%) after 12 weeks of treatment. The primary endpoint is the change in aortic characteristic impedance (Zc = dP/dQ in early systole) between baseline and Week 12.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* History of HTN and one of the following at BOTH screening and pre-randomization:\n\n 1. SBP \\>105 mm Hg on antihypertensive medication.\n 2. SBP \\>/= 140 mm Hg and NOT on antihypertensive medication.\n* NYHA class I-III heart failure and with reduced ejection fraction \\</= 40%, as determined by any local measurement made within the past 12 months using echocardiography, MUGA, CT scanning, MRI, ventricular angiography or single-photon emission computed tomography (SPECT), provided no subsequent measurement above 40%. Patients who have had an intervening medical event (e.g. myocardial infarction) or procedure (e.g. revascularization, cardiac resynchronization), must have a reassessment of EF ≥ 3 months following the event to ensure that eligibility criteria are still met.\n* On stable doses of treatment with guideline-directed therapy, other than ACEis and ARBs prior to randomization.\n\n 1. If the patient is currently taking an ACEi, a 36-hour washout is required prior to randomization (Visit 2).\n 2. If the patient is currently taking an ARB, they must discontinue the ARB before initiation of study treatment however washout is not required.\n* On an optimal medical regiment of diuretics and background medications to effectively treat co-morbidities such as HTN, DM, and coronary artery disease.\n\nKey Exclusion Criteria:\n\n* History of hypersensitivity to any of the study drigs, including history of hypersensitivity to drugs of similar chemical classes, or allergy to ACEis, ARBs, or NEP inhibitors as well as known or suspected contraindications to the study drugs.\n* Previous history of intolerance to sacubitril and valsartan, ACEi or ARB standard of care doses despite appropriate and gradual up-titration.\n* History of angioedema, drug-related or otherwise.\n* Requirement of treatment with both ACE inhibitor and ARB.\n* Current or prior treatment with sacubitril and valsartan.'}, 'identificationModule': {'nctId': 'NCT02874794', 'acronym': 'EVALUATE-HF', 'briefTitle': 'Study of Effects of Sacubitril/Valsartan vs. Enalapril on Aortic Stiffness in Patients With Mild to Moderate HF With Reduced Ejection Fraction', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Multicenter, Randomized, Double-blind, Double-dummy, Parallel Group, Active-controlled, Forced-titration, 12-week Comparison of Combined Angiotensin-neprilysin Inhibition With Sacubitril and Valsartan Versus Enalapril on Changes in Central Aortic Stiffness in Patients With Heart Failure and Reduced Ejection Fraction (HFrEF)', 'orgStudyIdInfo': {'id': 'CLCZ696BUS08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LCZ696 (sacubitril/valsartan)', 'description': 'minimum dose: 24/26mg, BID, oral, tablet maximum dose: 97/103mg, BID, oral, tablet All patients will begin on Dose Level 1 (24/26mg) and will be titrated every two weeks to target Dose level 3 (97/103mg). LCZ696 tablets will be provided for the 12-week open label extension.', 'interventionNames': ['Drug: LCZ696 (sacubitril/valsartan)', 'Drug: Placebo of Enalapril']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Enalapril', 'description': 'minimum dose: 2.5mg, BID, oral, tablet maximum dose: 10 mg, BID, oral tablet All patients will begin on Dose Level 1 (2.5mg) and will be titrated every two weeks to target Dose level 3 (10mg).', 'interventionNames': ['Drug: Enalapril', 'Drug: Placebo of LCZ696']}], 'interventions': [{'name': 'LCZ696 (sacubitril/valsartan)', 'type': 'DRUG', 'otherNames': ['LCZ696'], 'description': '24/26mg, 49/51mg and 97/103mg oral, tablets.', 'armGroupLabels': ['LCZ696 (sacubitril/valsartan)']}, {'name': 'Enalapril', 'type': 'DRUG', 'description': '2.5mg, 5mg, and 10mg, oral, tablets', 'armGroupLabels': ['Enalapril']}, {'name': 'Placebo of Enalapril', 'type': 'DRUG', 'description': 'matching placebo (2.5mg, 5mg and 10mg) oral, tablets', 'armGroupLabels': ['LCZ696 (sacubitril/valsartan)']}, {'name': 'Placebo of LCZ696', 'type': 'DRUG', 'description': 'matching placebo (24/26mg, 49/51mg and 97/103mg) oral, tablets', 'armGroupLabels': ['Enalapril']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294-0006', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '72202', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '90211', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '92648', 'city': 'Huntington Beach', 'state': 'California', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 33.6603, 'lon': -117.99923}}, {'zip': '92663', 'city': 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