Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2025-12-31 @ 12:23 PM
Study NCT ID:
NCT03988634
Status:
COMPLETED
Last Update Posted:
2025-03-06
First Post:
2019-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Changes in NT-proBNP, Safety, and Tolerability in HFpEF Patients With a WHF Event (HFpEF Decompensation) Who Have Been Stabilized and Initiated at the Time of or Within 30 Days Post-decompensation (PARAGLIDE-HF)
Sponsor:
Organization:
Raw JSON
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However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'No efficacy analyses include "OPEN LABEL\' data. After Protocol Amendment 01, the open-label option was removed from the study, only the 233 patients randomized in the Double-blind Phase Sacubitril+ Valsartan (LCZ696) and the 233 patients randomized in the Double-blind Phase Valsartan arms were included in the efficacy analysis.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.', 'description': 'Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.', 'eventGroups': [{'id': 'EG000', 'title': 'Double-blind Phase Sacubitril+ Valsartan (LCZ696)', 'description': 'Study treatment was titrated to the target dose of sacubitril/valsartan (LCZ696) 97/103 mg twice daily (Dose Level 3)', 'otherNumAtRisk': 233, 'deathsNumAtRisk': 233, 'otherNumAffected': 161, 'seriousNumAtRisk': 233, 'deathsNumAffected': 18, 'seriousNumAffected': 119}, {'id': 'EG001', 'title': 'Double-blind Phase Valsartan', 'description': 'Study treatment was titrated to the target dose of valsartan 160 mg twice daily (Dose Level 3).', 'otherNumAtRisk': 233, 'deathsNumAtRisk': 233, 'otherNumAffected': 165, 'seriousNumAtRisk': 233, 'deathsNumAffected': 26, 'seriousNumAffected': 117}, {'id': 'EG002', 'title': 'Open-label Phase Sacubitril+ Valsartan', 'description': 'Participants recruited under Protocol Version 00 (Original Protocol) and who had completed the double-blind phase before protocol amendment 01 was released. 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'EG001', 'numAtRisk': 233, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Glomerular filtration rate decreased', 'stats': 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'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 47}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Chronic kidney disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 58}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 40}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Blood loss anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Acute left ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Arrhythmia supraventricular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Atrial tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Atrioventricular block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'BRASH syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Cardiac amyloidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Cardiac failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Cardiac failure chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Cardiogenic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Chronic left ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Left ventricular dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Mitral valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Myocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Nodal arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Pulseless electrical activity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Right ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Sinus node dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 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'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Hypertensive emergency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Hypertensive urgency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Hypovolaemic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Peripheral artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Peripheral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Superficial vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time-averaged Proportional Change in NT proBNP From Baseline to Weeks 4 and 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sacubitril/Valsartan (LCZ696)', 'description': 'Study treatment was titrated to the target dose of sacubitril/valsartan (LCZ696) 97/103 mg twice daily (Dose Level 3).'}, {'id': 'OG001', 'title': 'Valsartan', 'description': 'Study treatment was titrated to the target dose of valsartan 160 mg twice daily (Dose Level 3).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.7200', 'groupId': 'OG000', 'lowerLimit': '0.6430', 'upperLimit': '0.8062'}, {'value': '0.8425', 'groupId': 'OG001', 'lowerLimit': '0.7561', 'upperLimit': '0.9387'}]}]}], 'analyses': [{'pValue': '0.0492', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8546', 'ciLowerLimit': '0.7307', 'ciUpperLimit': '0.9994', 'estimateComment': 'Geometric Mean Ratio: sac/val vs valsartan', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline, Average of Week 4 and Week 8', 'description': 'To demonstrate the effect of sacubitril/valsartan vs. valsartan on time-averaged proportional change in N-terminal pro-brain natriuretic peptide (NT-proBNP) from baseline to weeks 4 and 8 in heart failure with preserved ejection fraction (HFpEF) patients with a worsening heart failure event (HFpEF decompensation) who have been stabilized for and initiated at the time of or within 30 days post-decompensation.\n\nPlasma NT-proBNP (pg/mL) values were averaged from Week 4 and Week 8 visits. The change from baseline to average of Week 4 and Week 8 was expressed as the geometric mean of the ratio: Week - 8/Baseline.\n\nNT-proBNP is a protein produced in large amounts by the heart when it is not working properly, as in heart failure.\n\nBaseline value was the last non-missing assessment of plasma NT-proBNP before the first administration of study drug.', 'unitOfMeasure': 'Geometric Mean Ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set: All patients to whom study treatment was assigned by randomization and at least 1 dose of study treatment was received. Patients with missing baseline NT-proBNP and/or missing data from both Weeks 4 and 8 were not included in the primary analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Pairwise Comparisons With Wins or Ties in the Endpoint Adjudication Committee (EAC)-Adjudicated Composite Hierarchical Outcome', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}, {'value': '233', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'units': 'Pairwise comparison', 'counts': [{'value': '54289', 'groupId': 'OG000'}, {'value': '54289', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Sacubitril/Valsartan (LCZ696)', 'description': 'Study treatment was titrated to the target dose of sacubitril/valsartan (LCZ696) 97/103 mg twice daily (Dose Level 3).'}, {'id': 'OG001', 'title': 'Valsartan', 'description': 'Study treatment was titrated to the target dose of valsartan 160 mg twice daily (Dose Level 3).'}, {'id': 'OG002', 'title': 'Open-label Phase Sacubitril+ Valsartan', 'description': 'Participants recruited under Protocol Version 00 (Original Protocol) and who had completed the double-blind phase before protocol amendment 01 was released. Participants were in the open-label phase from Week 8 to Week 12.'}], 'classes': [{'title': 'Time to CV death wins', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}, {'value': '233', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'units': 'Pairwise comparison', 'counts': [{'value': '54289', 'groupId': 'OG000'}, {'value': '54289', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2170', 'groupId': 'OG000'}, {'value': '1536', 'groupId': 'OG001'}]}]}, {'title': 'Time to CV death ties', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}, {'value': '233', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'units': 'Pairwise comparison', 'counts': [{'value': '54289', 'groupId': 'OG000'}, {'value': '54289', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '50583', 'groupId': 'OG000'}, {'value': '50583', 'groupId': 'OG001'}]}]}, {'title': 'Number and times of HF hospitalizations during follow-up wins', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}, {'value': '233', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'units': 'Pairwise comparison', 'counts': [{'value': '50583', 'groupId': 'OG000'}, {'value': '50583', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6963', 'groupId': 'OG000'}, {'value': '6357', 'groupId': 'OG001'}]}]}, {'title': 'Number and times of HF hospitalizations during follow-up ties', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}, {'value': '233', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'units': 'Pairwise comparison', 'counts': [{'value': '50583', 'groupId': 'OG000'}, {'value': '50583', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '37263', 'groupId': 'OG000'}, {'value': '37263', 'groupId': 'OG001'}]}]}, {'title': 'Number and times of urgent HF visits during follow-up wins', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}, {'value': '233', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'units': 'Pairwise comparison', 'counts': [{'value': '37263', 'groupId': 'OG000'}, {'value': '37263', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '930', 'groupId': 'OG000'}, {'value': '572', 'groupId': 'OG001'}]}]}, {'title': 'Number and times of urgent HF visits during follow-up ties', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}, {'value': '233', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'units': 'Pairwise comparison', 'counts': [{'value': '37263', 'groupId': 'OG000'}, {'value': '37263', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '35761', 'groupId': 'OG000'}, {'value': '35761', 'groupId': 'OG001'}]}]}, {'title': 'Time-averaged proportional change in NT-proBNP wins', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}, {'value': '233', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'units': 'Pairwise comparison', 'counts': [{'value': '35761', 'groupId': 'OG000'}, {'value': '35761', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9987', 'groupId': 'OG000'}, {'value': '8343', 'groupId': 'OG001'}]}]}, {'title': 'Time-averaged proportional change in NT-proBNP ties', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}, {'value': '233', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'units': 'Pairwise comparison', 'counts': [{'value': '35761', 'groupId': 'OG000'}, {'value': '35761', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '17431', 'groupId': 'OG000'}, {'value': '17431', 'groupId': 'OG001'}]}]}, {'title': 'Overall wins', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}, {'value': '233', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'units': 'Pairwise comparison', 'counts': [{'value': '54289', 'groupId': 'OG000'}, {'value': '54289', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '20050', 'groupId': 'OG000'}, {'value': '16808', 'groupId': 'OG001'}]}]}, {'title': 'Overall ties', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}, {'value': '233', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'units': 'Pairwise comparison', 'counts': [{'value': '54289', 'groupId': 'OG000'}, {'value': '54289', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '17431', 'groupId': 'OG000'}, {'value': '17431', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1578', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Win Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.193', 'ciLowerLimit': '0.934', 'ciUpperLimit': '1.524', 'estimateComment': 'A win ratio greater than 1 was in favor of sacubitril/valsartan arm', 'statisticalMethod': 'unmatched pairwise win-ratio', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 84 weeks', 'description': 'This hierarchical composite endpoint consists of 4 ordered components: 1. Time to CV death, 2. Number and times of HF hospitalizations during follow-up, 3. Number and times of urgent HF visits during follow-up, 4. Time averaged proportional change in NT-proBNP from baseline to Weeks 4 and 8. This endpoint was analyzed estimating the unmatched win ratio by comparing every participant in the sacubitril/valsartan arm to every participant in the valsartan arm to determine a winner (unmatched pairing method). For every pair, a patient is labelled a \'winner\' (i.e. achieve a better clinical outcome) or a \'loser\'. Otherwise they are considered tied. The reported unit is the total "wins" or "ties" for each treatment group from performing such a hierarchical comparison.', 'unitOfMeasure': 'Pairwise comparisons', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Pairwise comparison', 'denomUnitsSelected': 'Pairwise comparison', 'populationDescription': 'Full analysis set: All patients included in the double-blind phase to whom study treatment was assigned by randomization and at least 1 dose of study treatment was received.'}, {'type': 'SECONDARY', 'title': 'EAC Adjudicated Recurrent Composite Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}, {'value': '233', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Sacubitril/Valsartan (LCZ696)', 'description': 'Study treatment was titrated to the target dose of sacubitril/valsartan (LCZ696) 97/103 mg twice daily (Dose Level 3).'}, {'id': 'OG001', 'title': 'Valsartan', 'description': 'Study treatment was titrated to the target dose of valsartan 160 mg twice daily (Dose Level 3).'}, {'id': 'OG002', 'title': 'Open-label Phase Sacubitril+ Valsartan', 'description': 'Participants recruited under Protocol Version 00 (Original Protocol) and who had completed the double-blind phase before protocol amendment 01 was released. Participants were in the open-label phase from Week 8 to Week 12.'}], 'classes': [{'categories': [{'measurements': [{'value': '63.519', 'groupId': 'OG000', 'lowerLimit': '51.330', 'upperLimit': '77.732'}, {'value': '76.189', 'groupId': 'OG001', 'lowerLimit': '63.010', 'upperLimit': '91.310'}]}]}], 'analyses': [{'pValue': '0.3563', 'groupIds': ['OG000', 'OG001'], 'paramType': 'rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8346', 'ciLowerLimit': '0.5684', 'ciUpperLimit': '1.2255', 'estimateComment': 'A rate ratio \\< 1 indicates an effect in favor of LCZ696', 'statisticalMethod': 'LWYY model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 84', 'description': 'This endpoint calculated the cumulative number of the following composite events over time:\n\n* CV death\n* recurrent HF hospitalizations\n* recurrent urgent HF visits The time to these recurrent events was analyzed using the semi-parametric proportional rates model (abbreviated as LWYY model).\n\nThe exposure-adjusted rate per 100 subject years (EAR) was calculated diving the total number of events by 100 subject years (total exposure up to event/censoring).\n\nThe role of the Endpoint Adjudication Committee (EAC) was to ensure that all treatment outcomes were judged uniformly, using standard criteria and processes.\n\nEvents that occurred in the double-blind treatment phase are included in the analysis.', 'unitOfMeasure': 'events per 100 subject years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set: All patients included in the double-blind phase to whom study treatment was assigned by randomization and at least 1 dose of study treatment was received.'}, {'type': 'SECONDARY', 'title': 'Total Number of Confirmed Incidences of a Composite Endpoint of Worsening Renal Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}, {'value': '233', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Sacubitril/Valsartan (LCZ696)', 'description': 'Study treatment was titrated to the target dose of sacubitril/valsartan (LCZ696) 97/103 mg twice daily (Dose Level 3).'}, {'id': 'OG001', 'title': 'Valsartan', 'description': 'Study treatment was titrated to the target dose of valsartan 160 mg twice daily (Dose Level 3).'}, {'id': 'OG002', 'title': 'Open-label Phase Sacubitril+ Valsartan', 'description': 'Participants recruited under Protocol Version 00 (Original Protocol) and who had completed the double-blind phase before protocol amendment 01 was released. Participants were in the open-label phase from Week 8 to Week 12.'}], 'classes': [{'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3155', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6249', 'ciLowerLimit': '0.2496', 'ciUpperLimit': '1.5649', 'statisticalMethod': 'negative binomial regression model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 84', 'description': 'This endpoint calculated the incidences of a composite endpoint of worsening renal function defined as:\n\n* renal death (from adverse events data)\n* reaching end-stage renal disease (ESRD) (Sustained eGFR \\<15mL/min/m2, chronic dialysis, or renal transplant)\n* ≥ 50% decline in estimated glomerular filtration rate (eGFR) relative to baseline \\[using central laboratory measurements (scheduled or unscheduled visits)\\]\n\nThe Investigator-reported AE and central laboratory data was used to identified event of interest in this secondary endpoint.\n\nEvents that occurred in the randomized double-blind treatment phase were included in the analysis.', 'unitOfMeasure': 'events of worsening renal function', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set: All patients included in the double-blind phase to whom study treatment was assigned by randomization and at least 1 dose of study treatment was received.'}, {'type': 'SECONDARY', 'title': 'Proportional Change in NT-proBNP From Baseline to Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sacubitril/Valsartan (LCZ696)', 'description': 'Study treatment was titrated to the target dose of sacubitril/valsartan (LCZ696) 97/103 mg twice daily (Dose Level 3).'}, {'id': 'OG001', 'title': 'Valsartan', 'description': 'Study treatment was titrated to the target dose of valsartan 160 mg twice daily (Dose Level 3).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.6778', 'groupId': 'OG000', 'lowerLimit': '0.5882', 'upperLimit': '0.7810'}, {'value': '0.7275', 'groupId': 'OG001', 'lowerLimit': '0.6359', 'upperLimit': '0.8323'}]}]}], 'analyses': [{'pValue': '0.4766', 'groupIds': ['OG000', 'OG001'], 'paramType': 'ratio of the change', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.9316', 'ciLowerLimit': '0.7661', 'ciUpperLimit': '1.1329', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline and Week 8', 'description': 'This endpoint intended to assess the effect of sacubitril/valsartan vs. valsartan on change in N-terminal pro-brain natriuretic peptide (NT-proBNP) from baseline to Week 8.\n\nNT-proBNP is a protein produced in large amounts by the heart when it is not working properly, as in heart failure.\n\nThe change from baseline to Week 8 was expressed as the geometric mean of the ratio: Week 8/Baseline.', 'unitOfMeasure': 'Geometric mean ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set: All patients to whom study treatment was assigned by randomization and at least 1 dose of study treatment was received. Patients with missing baseline NT-proBNP and/or missing data from Week 8 were not included in the this analysis'}, {'type': 'SECONDARY', 'title': 'Proportional Change From Baseline in Hs-Troponin at Weeks 4 and 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sacubitril/Valsartan (LCZ696)', 'description': 'Study treatment was titrated to the target dose of sacubitril/valsartan (LCZ696) 97/103 mg twice daily (Dose Level 3).'}, {'id': 'OG001', 'title': 'Valsartan', 'description': 'Study treatment was titrated to the target dose of valsartan 160 mg twice daily (Dose Level 3).'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.8124', 'groupId': 'OG000', 'lowerLimit': '0.76', 'upperLimit': '0.87'}, {'value': '0.9826', 'groupId': 'OG001', 'lowerLimit': '0.92', 'upperLimit': '1.05'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.7545', 'groupId': 'OG000', 'lowerLimit': '0.70', 'upperLimit': '0.81'}, {'value': '0.9310', 'groupId': 'OG001', 'lowerLimit': '0.87', 'upperLimit': '1.00'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'ratio of the change', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8268', 'ciLowerLimit': '0.76', 'ciUpperLimit': '0.91', 'groupDescription': 'Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'ratio of the change', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8103', 'ciLowerLimit': '0.74', 'ciUpperLimit': '0.89', 'groupDescription': 'Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline, Week 4 and Week 8', 'description': 'This endpoint intended to assess the effect of sacubitril/valsartan vs. valsartan on change from baseline in high sensitivity (hs)-Troponin at Weeks 4 and 8. Analysis was repeated for both the visits, Week 4 and Week 8 separately.\n\nHs-Troponin-T is a biomarker that is released from the heart under stress or injury conditions.\n\nThe change from baseline to Week 4 and Week 8 was expressed as the geometric mean of the ratio: Week 4 or Week 8/Baseline.', 'unitOfMeasure': 'Geometric mean ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set: All patients to whom study treatment was assigned by randomization and at least 1 dose of study treatment was received. Patients with missing baseline hs-Troponin and/or missing data from both Weeks 4 and 8 were not included in the this analysis'}, {'type': 'SECONDARY', 'title': 'Dosing Levels and Discontinuations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}, {'value': '233', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Sacubitril/Valsartan (LCZ696)', 'description': 'Study treatment was titrated to the target dose of sacubitril/valsartan (LCZ696) 97/103 mg twice daily (Dose Level 3).'}, {'id': 'OG001', 'title': 'Valsartan', 'description': 'Study treatment was titrated to the target dose of valsartan 160 mg twice daily (Dose Level 3).'}, {'id': 'OG002', 'title': 'Open-label Phase Sacubitril+ Valsartan', 'description': 'Participants recruited under Protocol Version 00 (Original Protocol) and who had completed the double-blind phase before protocol amendment 01 was released. Participants were in the open-label phase from Week 8 to Week 12.'}], 'classes': [{'title': 'Participants Randomized In-Hospital ; Timepoint: Randomization (initial dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Dose Level 1', 'measurements': [{'value': '133', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}, {'title': 'Dose Level 2', 'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}, {'title': 'Dose Level 3', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'No Treatment', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Off Treatment', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Participants Randomized In-Hospital ; Timepoint: Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Dose Level 1', 'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}, {'title': 'Dose Level 2', 'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}, {'title': 'Dose Level 3', 'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}, {'title': 'No Treatment', 'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}, {'title': 'Off Treatment', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Participants Randomized In-Hospital ; Timepoint: Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Dose Level 1', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}, {'title': 'Dose Level 2', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}, {'title': 'Dose Level 3', 'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}, {'title': 'No Treatment', 'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}, {'title': 'Off Treatment', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Participants Randomized Out-of-hospital; Timepoint: Randomization (Initial Dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Dose Level 1', 'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}, {'title': 'Dose Level 2', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}, {'title': 'Dose Level 3', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'No Treatment', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Off Treatment', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Participants Randomized Out-of-hospital; Timepoint: Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Dose Level 1', 'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}, {'title': 'Dose Level 2', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}, {'title': 'Dose Level 3', 'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}, {'title': 'No Treatment', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': 'Off Treatment', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Participants Randomized Out-of-hospital; Timepoint: Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Dose Level 1', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}, {'title': 'Dose Level 2', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}, {'title': 'Dose Level 3', 'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}, {'title': 'No Treatment', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}, {'title': 'Off Treatment', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Randomization, Week 8, Week 24', 'description': 'The dosing level has been summarized by treatment group and in-/out-of-hospital randomization status. The dose levels used were:\n\nDose Level 1: 40 mg valsartan or 24/26 mg \\[50 mg\\] LCZ696, BID; Dose Level 2: 80 mg valsartan or 49/51 mg \\[100 mg\\] LCZ696, BID; Dose Level 3: 160 mg valsartan or 97/103 mg \\[200 mg\\] LCZ696, BID\n\nPatients counted as "Off Treatment" are those who prematurely permanently discontinued study treatment but continued with visits.\n\nPatients counted as "No Treatment" are those who permanently discontinued with both study treatment and study visits', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set: All patients included in the double-blind phase to whom study treatment was assigned by randomization and at least 1 dose of study treatment was received'}, {'type': 'SECONDARY', 'title': 'Incidence of Adverse Events of Special Interest (AESI) During Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}, {'value': '233', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Sacubitril/Valsartan (LCZ696)', 'description': 'Study treatment was titrated to the target dose of sacubitril/valsartan (LCZ696) 97/103 mg twice daily (Dose Level 3).'}, {'id': 'OG001', 'title': 'Valsartan', 'description': 'Study treatment was titrated to the target dose of valsartan 160 mg twice daily (Dose Level 3).'}, {'id': 'OG002', 'title': 'Open-label Phase Sacubitril+ Valsartan', 'description': 'Participants recruited under Protocol Version 00 (Original Protocol) and who had completed the double-blind phase before protocol amendment 01 was released. Participants were in the open-label phase from Week 8 to Week 12.'}], 'classes': [{'title': 'Symptomatic hypotension', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}, {'title': 'Hyperkalemia', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}]}, {'title': 'Angioedema', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Worsening renal function', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to week 84', 'description': 'This endpoint intended to calculate the incidence of the following adverse events of special interest (AESI) during treatment:\n\nSymptomatic hypotension, Hyperkalemia (potassium \\> 5.5 mEq/L), Angioedema and worsening renal function (defined as an increase in serum creatinine of ≥ 0.5 mg/dL and worsening of the eGFR by at least 25%)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set: All patients included in the double-blind phase to whom study treatment was assigned by randomization and at least 1 dose of study treatment was received.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Double-blind Phase Sacubitril+ Valsartan (LCZ696)', 'description': 'Study treatment was titrated to the target dose of sacubitril/valsartan (LCZ696) 97/103 mg twice daily (Dose Level 3).'}, {'id': 'FG001', 'title': 'Double-blind Phase Valsartan', 'description': 'Study treatment was titrated to the target dose of valsartan 160 mg twice daily (Dose Level 3).'}, {'id': 'FG002', 'title': 'Open-label Phase Sacubitril+ Valsartan', 'description': 'Participants recruited under Protocol Version 00 (Original Protocol) and who had completed the double-blind phase before protocol amendment 01 was released. Participants were in the open-label phase from Week 8 to Week 12.'}], 'periods': [{'title': 'Double-Blind', 'milestones': [{'type': 'STARTED', 'comment': 'Randomized', 'achievements': [{'groupId': 'FG000', 'numSubjects': '234'}, {'groupId': 'FG001', 'numSubjects': '233'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Treated Patients', 'achievements': [{'groupId': 'FG000', 'numSubjects': '233'}, {'groupId': 'FG001', 'numSubjects': '233'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '173'}, {'groupId': 'FG001', 'numSubjects': '182'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '51'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '26'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Subject decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Open-Label', 'milestones': [{'type': 'STARTED', 'comment': 'Started open label phase under Protocol Version 00', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '41'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Technical problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Of 586 patients screened for the study, 467 patients were randomized to receive treatment, and 466 randomized patients were treated. The study had 90 sites in the US and 10 sites in Canada', 'preAssignmentDetails': 'Patients were randomized 1:1 to sacubitril/valsartan or valsartan. Randomized patients were deemed hemodynamically stabilized and needed to meet all inclusion and none of the exclusion criteria. At the randomization visit, all eligible patients were randomized via interactive response technology to one of the treatment arms.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'BG000'}, {'value': '233', 'groupId': 'BG001'}, {'value': '466', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Sacubitril/Valsartan (LCZ696)', 'description': 'Study treatment was titrated to the target dose of sacubitril/valsartan (LCZ696) 97/103 mg twice daily (Dose Level 3).'}, {'id': 'BG001', 'title': 'Valsartan', 'description': 'Study treatment was titrated to the target dose of valsartan 160 mg twice daily (Dose Level 3).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '69.2', 'spread': '11.95', 'groupId': 'BG000'}, {'value': '70.5', 'spread': '11.56', 'groupId': 'BG001'}, {'value': '69.8', 'spread': '11.76', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '121', 'groupId': 'BG000'}, {'value': '121', 'groupId': 'BG001'}, {'value': '242', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '112', 'groupId': 'BG000'}, {'value': '112', 'groupId': 'BG001'}, {'value': '224', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'White', 'measurements': [{'value': '176', 'groupId': 'BG000'}, {'value': '176', 'groupId': 'BG001'}, {'value': '352', 'groupId': 'BG002'}]}, {'title': 'Black', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'American Indian or Alaska Native', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Demographic and baseline characteristics are based on the full analysis set (FAS), as primary and secondary analysis are based on the FAS.\n\nThe FAS consisted of all patients to whom study treatment was assigned by randomization and at least 1 dose of study treatment received.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-12-08', 'size': 2609281, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-11-22T12:02', 'hasProtocol': True}, {'date': '2023-02-21', 'size': 1646109, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-11-22T12:02', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 467}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2022-12-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-04', 'studyFirstSubmitDate': '2019-06-13', 'resultsFirstSubmitDate': '2023-11-22', 'studyFirstSubmitQcDate': '2019-06-13', 'lastUpdatePostDateStruct': {'date': '2025-03-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-07-25', 'studyFirstPostDateStruct': {'date': '2019-06-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-07-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time-averaged Proportional Change in NT proBNP From Baseline to Weeks 4 and 8', 'timeFrame': 'Baseline, Average of Week 4 and Week 8', 'description': 'To demonstrate the effect of sacubitril/valsartan vs. valsartan on time-averaged proportional change in N-terminal pro-brain natriuretic peptide (NT-proBNP) from baseline to weeks 4 and 8 in heart failure with preserved ejection fraction (HFpEF) patients with a worsening heart failure event (HFpEF decompensation) who have been stabilized for and initiated at the time of or within 30 days post-decompensation.\n\nPlasma NT-proBNP (pg/mL) values were averaged from Week 4 and Week 8 visits. The change from baseline to average of Week 4 and Week 8 was expressed as the geometric mean of the ratio: Week - 8/Baseline.\n\nNT-proBNP is a protein produced in large amounts by the heart when it is not working properly, as in heart failure.\n\nBaseline value was the last non-missing assessment of plasma NT-proBNP before the first administration of study drug.'}], 'secondaryOutcomes': [{'measure': 'Number of Pairwise Comparisons With Wins or Ties in the Endpoint Adjudication Committee (EAC)-Adjudicated Composite Hierarchical Outcome', 'timeFrame': 'Up to 84 weeks', 'description': 'This hierarchical composite endpoint consists of 4 ordered components: 1. Time to CV death, 2. Number and times of HF hospitalizations during follow-up, 3. Number and times of urgent HF visits during follow-up, 4. Time averaged proportional change in NT-proBNP from baseline to Weeks 4 and 8. This endpoint was analyzed estimating the unmatched win ratio by comparing every participant in the sacubitril/valsartan arm to every participant in the valsartan arm to determine a winner (unmatched pairing method). For every pair, a patient is labelled a \'winner\' (i.e. achieve a better clinical outcome) or a \'loser\'. Otherwise they are considered tied. The reported unit is the total "wins" or "ties" for each treatment group from performing such a hierarchical comparison.'}, {'measure': 'EAC Adjudicated Recurrent Composite Events', 'timeFrame': 'Up to Week 84', 'description': 'This endpoint calculated the cumulative number of the following composite events over time:\n\n* CV death\n* recurrent HF hospitalizations\n* recurrent urgent HF visits The time to these recurrent events was analyzed using the semi-parametric proportional rates model (abbreviated as LWYY model).\n\nThe exposure-adjusted rate per 100 subject years (EAR) was calculated diving the total number of events by 100 subject years (total exposure up to event/censoring).\n\nThe role of the Endpoint Adjudication Committee (EAC) was to ensure that all treatment outcomes were judged uniformly, using standard criteria and processes.\n\nEvents that occurred in the double-blind treatment phase are included in the analysis.'}, {'measure': 'Total Number of Confirmed Incidences of a Composite Endpoint of Worsening Renal Function', 'timeFrame': 'Up to Week 84', 'description': 'This endpoint calculated the incidences of a composite endpoint of worsening renal function defined as:\n\n* renal death (from adverse events data)\n* reaching end-stage renal disease (ESRD) (Sustained eGFR \\<15mL/min/m2, chronic dialysis, or renal transplant)\n* ≥ 50% decline in estimated glomerular filtration rate (eGFR) relative to baseline \\[using central laboratory measurements (scheduled or unscheduled visits)\\]\n\nThe Investigator-reported AE and central laboratory data was used to identified event of interest in this secondary endpoint.\n\nEvents that occurred in the randomized double-blind treatment phase were included in the analysis.'}, {'measure': 'Proportional Change in NT-proBNP From Baseline to Week 8', 'timeFrame': 'Baseline and Week 8', 'description': 'This endpoint intended to assess the effect of sacubitril/valsartan vs. valsartan on change in N-terminal pro-brain natriuretic peptide (NT-proBNP) from baseline to Week 8.\n\nNT-proBNP is a protein produced in large amounts by the heart when it is not working properly, as in heart failure.\n\nThe change from baseline to Week 8 was expressed as the geometric mean of the ratio: Week 8/Baseline.'}, {'measure': 'Proportional Change From Baseline in Hs-Troponin at Weeks 4 and 8', 'timeFrame': 'Baseline, Week 4 and Week 8', 'description': 'This endpoint intended to assess the effect of sacubitril/valsartan vs. valsartan on change from baseline in high sensitivity (hs)-Troponin at Weeks 4 and 8. Analysis was repeated for both the visits, Week 4 and Week 8 separately.\n\nHs-Troponin-T is a biomarker that is released from the heart under stress or injury conditions.\n\nThe change from baseline to Week 4 and Week 8 was expressed as the geometric mean of the ratio: Week 4 or Week 8/Baseline.'}, {'measure': 'Dosing Levels and Discontinuations', 'timeFrame': 'Randomization, Week 8, Week 24', 'description': 'The dosing level has been summarized by treatment group and in-/out-of-hospital randomization status. The dose levels used were:\n\nDose Level 1: 40 mg valsartan or 24/26 mg \\[50 mg\\] LCZ696, BID; Dose Level 2: 80 mg valsartan or 49/51 mg \\[100 mg\\] LCZ696, BID; Dose Level 3: 160 mg valsartan or 97/103 mg \\[200 mg\\] LCZ696, BID\n\nPatients counted as "Off Treatment" are those who prematurely permanently discontinued study treatment but continued with visits.\n\nPatients counted as "No Treatment" are those who permanently discontinued with both study treatment and study visits'}, {'measure': 'Incidence of Adverse Events of Special Interest (AESI) During Treatment', 'timeFrame': 'Up to week 84', 'description': 'This endpoint intended to calculate the incidence of the following adverse events of special interest (AESI) during treatment:\n\nSymptomatic hypotension, Hyperkalemia (potassium \\> 5.5 mEq/L), Angioedema and worsening renal function (defined as an increase in serum creatinine of ≥ 0.5 mg/dL and worsening of the eGFR by at least 25%)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Heart failure with preserved ejection fraction (HFpEF)', 'Heart failure hospitalization', 'NYHA', 'NT-proBNP', 'Acute decompensated heart failure', 'Sacubitril/valsartan', 'Global evaluation of treatment effectiveness (GETE)', 'Worsening Heart Failure'], 'conditions': ['Heart Failure With Preserved Ejection Fraction (HFpEF)']}, 'referencesModule': {'references': [{'pmid': '40268180', 'type': 'DERIVED', 'citation': 'Peters AE, Li S, Cyr D, Williamson KM, Zieroth S, Fudim M, Ward JH, Mentz RJ. Influence of ejection fraction on outcomes with sacubitril/valsartan in patients with worsening heart failure with EF>40%: The PARAGLIDE-HF Trial. Am Heart J. 2025 Nov;289:158-167. doi: 10.1016/j.ahj.2025.04.023. Epub 2025 Apr 21.'}, {'pmid': '40174692', 'type': 'DERIVED', 'citation': 'Rambarat P, Erickson T, Cyr D, Ward J, Hernandez A, Morrow D, Starling R, Velazquez E, Zieroth S, Williamson K, Solomon S, Mentz R. Effects of angiotensin-neprilysin inhibition in women vs men: Insights from PARAGLIDE-HF. Am Heart J. 2025 Oct;288:41-51. doi: 10.1016/j.ahj.2025.03.017. Epub 2025 Mar 31.'}, {'pmid': '39505123', 'type': 'DERIVED', 'citation': 'Shoji S, Cyr DD, Hernandez AF, Velazquez EJ, Ward JH, Williamson KM, Sarwat S, Starling RC, Desai AS, Zieroth S, Solomon SD, Mentz RJ. Win Ratio Analyses Using a Modified Hierarchical Composite Outcome: Insights From PARAGLIDE-HF. Am Heart J. 2025 Feb;280:70-78. doi: 10.1016/j.ahj.2024.10.020. Epub 2024 Nov 4.'}, {'pmid': '38802053', 'type': 'DERIVED', 'citation': 'Fudim M, Cyr DD, Ward JH, Hernandez AF, Lepage S, Morrow DA, Sharma K, Claggett BL, Starling RC, Velazquez EJ, Williamson KM, Desai AS, Zieroth S, Solomon SD, Braunwald E, Mentz RJ; PARAGLIDE-HF investigators. Association of Sacubitril/Valsartan vs Valsartan With Blood Pressure Changes and Symptomatic Hypotension: the PARAGLIDE-HF Trial. J Card Fail. 2024 Dec;30(12):1568-1577. doi: 10.1016/j.cardfail.2024.04.030. Epub 2024 May 26.'}, {'pmid': '38508844', 'type': 'DERIVED', 'citation': 'Morrow DA, Velazquez EJ, Desai AS, DeVore AD, Lepage S, Park JG, Sharma K, Solomon SD, Starling RC, Ward JH, Williamson KM, Zieroth S, Hernandez AF, Mentz RJ, Braunwald E. Sacubitril/Valsartan in Patients Hospitalized With Decompensated Heart Failure. J Am Coll Cardiol. 2024 Mar 26;83(12):1123-1132. doi: 10.1016/j.jacc.2024.01.027.'}, {'pmid': '37212758', 'type': 'DERIVED', 'citation': 'Mentz RJ, Ward JH, Hernandez AF, Lepage S, Morrow DA, Sarwat S, Sharma K, Starling RC, Velazquez EJ, Williamson KM, Desai AS, Zieroth S, Solomon SD, Braunwald E; PARAGLIDE-HF Investigators. Angiotensin-Neprilysin Inhibition in Patients With Mildly Reduced or Preserved Ejection Fraction and Worsening Heart Failure. J Am Coll Cardiol. 2023 Jul 4;82(1):1-12. doi: 10.1016/j.jacc.2023.04.019. Epub 2023 May 21.'}], 'seeAlsoLinks': [{'url': 'https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=1801', 'label': 'A Plain Language Trial Summary is available at www.novctrd.com'}]}, 'descriptionModule': {'briefSummary': 'The effect of sacubitril/valsartan vs. valsartan on changes in NT-proBNP, safety, and tolerability in HFpEF patients with a WHF event (HFpEF decompensation) who had been stabilized and initiated at the time of or within 30 days post-decompensation.', 'detailedDescription': 'This study used a randomized, double-blind, double-dummy, active-controlled, parallel group design conducted across 100 centers in the US and Canada. The study duration was a maximum of 20 months (minimum follow up was 8 weeks).\n\nRandomized patients were deemed hemodynamically stabilized and needed to meet all inclusion and none of the exclusion criteria. Patients were randomized 1:1 to LCZ696 or valsartan. Initial dose at randomization was determined based on the patient\'s previous dose of or lack of ACEi/angiotensin receptor blocker (ARB) immediately prior to current worsening heart failure (WHF) event (heart failure with preserved ejection fraction \\[HFpEF\\]) decompensation, or at the time of post-decompensation randomization.\n\nLCZ696 dose or valsartan dose levels may have been increased to the targeted desired dose of 97/103 mg \\[200 mg\\] BID or valsartan 160 mg BID on an every 2-week basis or earlier based on clinical need and investigator judgment. Every effort was made to titrate to and maintain patients on the target dose level, as tolerated by the patient.\n\nTo maintain the blinding, patients were required to take their assigned active treatment tablet along with placebo matching the opposite treatment BID.\n\nThe protocol had 4 amendments. Protocol Version 00 (Original Protocol) included a double-blind phase through Week 8 followed by an open-label phase during Weeks 8 to 12. Protocol Amendment 01 omitted the open-label phase and followed patients for a maximum of 20 months in a double-blinded treatment phase. Throughout all protocol versions, the primary endpoint remained the time-averaged proportional change in N-terminal pro-brain natriuretic peptide (NT-proBNP) from Baseline to Weeks 4 and 8. The most recent protocol amendment (Amendment 04) reduced the sample size to approximately 450 patients (from 800) with 85% power for the primary endpoint, deemphasizing the statistical power for key secondary clinical endpoints; however, clinical events were still assessed as secondary endpoints.\n\nNo efficacy analyses include "OPEN LABEL\' data. After Protocol Amendment 01, the open-label option was removed from the study, only the 233 patients randomized in the Double-blind Phase Sacubitril+ Valsartan (LCZ696) and the 233 patients randomized in the Double-blind Phase Valsartan arms were included in the efficacy analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "INCLUSION CRITERIA:\n\n1. Signed informed consent must be obtained prior to participation in the study\n2. Patients \\>=18 years of age, male or female\n3. Current hospitalization for Worsening Heart Failure (WHF) (HFpEF decompensation), or within 30 days of discharge following a WHF event (defined as hospitalization, emergency department (ED) visit or out-of-hospital urgent HF visit, all requiring IV diuretics). Patients with a diagnosis of acute heart failure had to have symptoms and signs of fluid overload (i.e. jugular venous distention, edema or rales on auscultation or pulmonary congestion on chest x-ray). Eligible patients were randomized after IV diuresis for HFpEF is given (and no earlier than 36 hours from their last ACEi dose if applicable) and within 30 days post-decompensation after presentation with acute HFpEF decompensation and meeting the following definitions of hemodynamic stability:\n\n Randomized patients were hemodynamically stable defined in this study as:\n 1. SBP \\>=100mmHg for the preceding 6 hours prior to randomization; no symptomatic hypotension\n 2. No increase (intensification) in IV diuretic dose within last 6 hours prior to randomization\n 3. No IV inotropic drugs for 24 hours prior to randomization\n 4. No IV vasodilators including nitrates within last 6 hours prior to randomization\n4. HFpEF with most recent LVEF \\> 40% (within past 3 months)\n5. Elevated NT-proBNP or BNP at the time of acute HFpEF decompensation or post-decompensation screening (and within 72 hours for out-of-hospital randomization, if applicable):\n\n 1. Patients not in Atrial Fibrillation(AF) at the time of biomarker assessment: NT-proBNP \\>= 500pg/mL or BNP \\>= 150 pg/mL; patients in AF at the time of biomarker assessment: NT-proBNP \\>= 1000pg/mL or BNP \\>= 300 pg/mL\n 2. Patients recruited in-hospital were randomized based on the qualifying local lab value in-hospital NT-proBNP or BNP value.\n 3. Patients enrolled post-decompensation can be randomized based on their NT-proBNP or BNP value in the following way:\n\n i. if enrolling in post-decompensation setting then need eligible screening/local NTproBNP/BNP within 72 hours of randomization. The test value could be from recent hospitalization if within 72 hours or ii. would require (re)drawing NT-proBNP or BNP labs in post-decompensation setting if the lab value is not already available within the last 72 hours).\n\n6\\) Has not taken an ACEi for 36 hours prior to randomization\n\nEXCLUSION CRITERIA:\n\n1. Any clinical event within the 90 days prior to randomization that could have reduced the LVEF (i.e., myocardial infarction (MI), coronary artery bypass graft (CABG), unless an echo measurement was performed after the event confirming the LVEF to be \\> 40%\n2. Entresto™ (sacubitril/valsartan) usage within the past 60 days\n3. eGFR \\< 20ml/min/1.73 m2 as measured by the simplified Modification of Diet in Renal Disease (MDRD) formula at most recent assessment prior to randomization and within 24 hours prior to inpatient randomization or 72 hours prior to outpatient randomization\n4. Serum potassium \\> 5.2 mEq/L at most recent assessment prior to randomization and within 24 hours prior to inpatient randomization or 72 hours prior to outpatient randomization\n5. Acute coronary syndrome, stroke, transient ischemic attack; cardiac, carotid or other major CV surgery; percutaneous coronary intervention (PCI) or carotid angioplasty, within 30 days prior to randomization\n6. Probable alternative diagnoses that in the opinion of the investigator could account for the patient's HF symptoms (i.e. dyspnea, fatigue) such as significant pulmonary disease (including primary pulmonary HTN), anemia or obesity.\n7. Isolated right HF in the absence of left-sided structural heart disease\n8. History of hypersensitivity (i.e. including angioedema), known or suspected contraindications, or intolerance to any of the study drugs including ARNIs (i.e. sacubitril/valsartan), and/or ARBs\n9. Patients with a known history of angioedema due to any etiology\n10. Patients with a history of heart transplant or LVAD, currently on the transplant list, or with planned intent to implant LVAD or CRT device within the initial three months of enrollment during the trial\n11. A cardiac or non-cardiac medical condition other than HF with an estimated life expectancy of \\< 6 months\n12. Known pericardial constriction, genetic hypertrophic cardiomyopathy, or infiltrative cardiomyopathy including suspected or confirmed amyloid heart disease (amyloidosis)\n13. Life-threatening or uncontrolled dysrhythmia, including symptomatic or sustained ventricular tachycardia and atrial fibrillation or flutter with a resting ventricular rate \\> 110 bpm\n14. Clinically significant congenital heart disease felt to be the cause of the patient's symptoms and signs of HF\n15. Coronary or carotid artery disease or valvular heart disease likely to require surgical or percutaneous intervention within the duration of the trial\n16. Any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study\n17. Known hepatic impairment (as evidenced by total bilirubin \\> 3 mg/dL, or increased ammonia levels, if performed), or history of cirrhosis with evidence of portal hypertension such as varices\n18. Participation in any other clinical trial involving investigational agents or devices within the past 30 days\n19. Current confirmed COVID19 infection\n20. Past COVID19 infection with persistent symptom burden suspected due to COVID19 (further defined in Section 5.2).\n21. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.\n22. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing of investigational drug and for 7 days off of study drug. Highly effective contraception methods are defined in protocol."}, 'identificationModule': {'nctId': 'NCT03988634', 'acronym': 'PARAGLIDE-HF', 'briefTitle': 'Changes in NT-proBNP, Safety, and Tolerability in HFpEF Patients With a WHF Event (HFpEF Decompensation) Who Have Been Stabilized and Initiated at the Time of or Within 30 Days Post-decompensation (PARAGLIDE-HF)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Multicenter, Randomized, Double-blind, Double Dummy, Parallel Group, Active-controlled Study to Evaluate the Effect of Sacubitril/Valsartan (LCZ696) Versus Valsartan on Changes in NT-proBNP, Safety, and Tolerability in HFpEF Patients With a WHF Event (HFpEF Decompensation) Who Have Been Stabilized and Initiated at the Time of or Within 30 Days Post-decompensation (PARAGLIDE-HF)', 'orgStudyIdInfo': {'id': 'CLCZ696DUS01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'sacubitril/valsartan (LCZ696)', 'description': 'Study treatment was titrated to the target dose of sacubitril/valsartan (LCZ696) 97/103 mg twice daily (Dose Level 3).\n\nPatients were required to take a total of two tablets twice daily (one tablet of active sacubitril and valsartan , and one tablet of valsartan matching placebo)', 'interventionNames': ['Drug: sacubitril/valsartan', 'Drug: valsartan matching placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'valsartan', 'description': 'Study treatment was titrated to the target dose of valsartan 160 mg twice daily (Dose Level 3).\n\nPatients were required to take a total of two tablets twice daily (one tablet of active valsartan, and one tablet of sacubitril and valsartan matching placebo)', 'interventionNames': ['Drug: valsartan', 'Drug: sacubitril/valsartan matching placebo']}], 'interventions': [{'name': 'sacubitril/valsartan', 'type': 'DRUG', 'otherNames': ['LCZ696'], 'description': 'Sacubitril/valsartan (LCZ696) was available as 24/26 mg, 49/51 mg, and 97/103 mg in tablet form to be taken orally, twice daily', 'armGroupLabels': ['sacubitril/valsartan (LCZ696)']}, {'name': 'valsartan', 'type': 'DRUG', 'description': 'Valsartan was available as 40 mg, 80 mg, and 160 mg in tablet form to be taken orally, twice daily', 'armGroupLabels': ['valsartan']}, {'name': 'sacubitril/valsartan matching placebo', 'type': 'DRUG', 'description': 'Sacubitril/valsartan (LCZ696) matching placebo was available as tablet form to be taken orally, twice daily', 'armGroupLabels': ['valsartan']}, {'name': 'valsartan matching placebo', 'type': 'DRUG', 'description': 'Valsartan matching placebo was available as tablet form to be taken orally, twice daily', 'armGroupLabels': ['sacubitril/valsartan (LCZ696)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92660', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'University of Calif Irvine Med Cntr', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}, {'zip': '90806', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Memorial Care Health System Memorialcare Long Beach', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '90033-4605', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University Of Southern California .', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90033-4605', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University Of Southern California', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'San Diego Cardiac Center', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94110', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Zuckerberg General W84 Research .', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94806', 'city': 'San Pablo', 'state': 'California', 'country': 'United States', 'facility': 'Sutter Health Network .', 'geoPoint': {'lat': 37.96215, 'lon': -122.34553}}, {'zip': '92704', 'city': 'Santa Ana', 'state': 'California', 'country': 'United States', 'facility': 'Helping Hands Medical Associates INC', 'geoPoint': {'lat': 33.74557, 'lon': -117.86783}}, {'zip': '80923', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'St Francis Medical Center', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '80228', 'city': 'Lakewood', 'state': 'Colorado', 'country': 'United States', 'facility': 'Colorado Heart and Vascular .', 'geoPoint': {'lat': 39.70471, 'lon': -105.08137}}, {'zip': '80120', 'city': 'Littleton', 'state': 'Colorado', 'country': 'United States', 'facility': 'South Denver Cardiology Associates PC', 'geoPoint': {'lat': 39.61332, 'lon': -105.01665}}, {'zip': '06109', 'city': 'West Hartford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Hartford 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{'lat': 30.33218, 'lon': -81.65565}}, {'zip': '34239', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Intercoastal Medical Group', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '30310', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Morehouse School Of Medicine', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University School of Medicine/Winship Cancer Institute', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30901', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'University Cardiology Associates', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '83702', 'city': 'Boise', 'state': 'Idaho', 'country': 'United States', 'facility': 'St Lukes Idaho Cardiology Associates CLCZ696BUS13', 'geoPoint': {'lat': 43.6135, 'lon': -116.20345}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago .', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60007', 'city': 'Elk Grove Village', 'state': 'Illinois', 'country': 'United States', 'facility': 'Amita Health', 'geoPoint': {'lat': 42.00392, 'lon': -87.97035}}, {'zip': '60181', 'city': 'Oakbrook Terrace', 'state': 'Illinois', 'country': 'United States', 'facility': 'Midwest Cardiovascular Institute .', 'geoPoint': {'lat': 41.85003, 'lon': -87.96451}}, {'zip': '60068', 'city': 'Park Ridge', 'state': 'Illinois', 'country': 'United States', 'facility': 'Advocate Medical Group .', 'geoPoint': {'lat': 42.01114, 'lon': -87.84062}}, {'zip': '61606', 'city': 'Peoria', 'state': 'Illinois', 'country': 'United States', 'facility': 'Unity Point Health Methodist', 'geoPoint': {'lat': 40.69365, 'lon': -89.58899}}, {'zip': '61614', 'city': 'Peoria', 'state': 'Illinois', 'country': 'United States', 'facility': 'OSF HealthCare', 'geoPoint': {'lat': 40.69365, 'lon': -89.58899}}, {'zip': '60190', 'city': 'Winfield', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern Medicine Northwestern University', 'geoPoint': {'lat': 41.8617, 'lon': -88.1609}}, {'zip': '46514', 'city': 'Elkhart', 'state': 'Indiana', 'country': 'United States', 'facility': 'Midwest Cardiovascular Research and Education Foundation .', 'geoPoint': {'lat': 41.68199, 'lon': -85.97667}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University Health', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '46237', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Franciscan Health Services Research Center .', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '47303', 'city': 'Muncie', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University Health', 'geoPoint': {'lat': 40.19338, 'lon': -85.38636}}, {'zip': '47374', 'city': 'Richmond', 'state': 'Indiana', 'country': 'United States', 'facility': 'Reid Hosp And Hlth Care Services', 'geoPoint': {'lat': 39.82894, 'lon': -84.89024}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'The Uni of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '71301', 'city': 'Alexandria', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Alexandria Cardiology Clinic', 'geoPoint': {'lat': 31.31129, 'lon': -92.44514}}, {'zip': '70808', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'The Franciscan Missionaries', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}, {'zip': '04401', 'city': 'Bangor', 'state': 'Maine', 'country': 'United States', 'facility': 'Northern Light Easter Maine Medical Center .', 'geoPoint': {'lat': 44.79884, 'lon': -68.77265}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Univ School of Med', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21804', 'city': 'Salisbury', 'state': 'Maryland', 'country': 'United States', 'facility': 'Tidal Health Peninsula Regional Inc .', 'geoPoint': {'lat': 38.36067, 'lon': -75.59937}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston Univeristy Medical Center .', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Med Ctr CLCZ696D2301', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Hs', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Detroit Medical Center Cardiovascular Clinical Trial .', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Hospital Cardiovascular Medicine', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '48197', 'city': 'Ypsilanti', 'state': 'Michigan', 'country': 'United States', 'facility': 'Trinity Health Michigan Heart .', 'geoPoint': {'lat': 42.24115, 'lon': -83.61299}}, {'zip': '55101', 'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}, {'zip': '39216', 'city': 'Jackson', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Jackson Heart Clinic', 'geoPoint': {'lat': 32.29876, 'lon': -90.18481}}, {'zip': '68510', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Nebraska Heart Institute CHI Health Nebraska', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '68198', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'University of Nebraska Medical Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '89201', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Univ Medical Center Las Vegas', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '89502', 'city': 'Reno', 'state': 'Nevada', 'country': 'United States', 'facility': 'R Ins For Heart And Vascular Health', 'geoPoint': {'lat': 39.52963, 'lon': -119.8138}}, {'zip': '08318', 'city': 'Elmer', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Inspira Health Network', 'geoPoint': {'lat': 39.59511, 'lon': -75.17018}}, {'zip': '08035', 'city': 'Haddon Heights', 'state': 'New Jersey', 'country': 'United 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