Phase 4Completed
Efficacy and Safety of Sacubitril/Valsartan Compared With Enalapril on Morbidity, Mortality, and NT-proBNP Change in Patients With CCC (PARACHUTE-HF)
A Multicenter, Prospective, Randomized, Open-label, Blinded-endpoint, Phase 4 Study to Evaluate the Efficacy and Safety of Sacubitril/Valsartan Compared With Enalapril on Morbidity, Mortality, and NT-proBNP Change in Patients With Chronic Chagas' Cardiomyopathy. The Study is Also Know as Prevention And Reduction of Adverse Outcomes in Chagasic Heart failUre Trial Evaluation (PARACHUTE-HF).
- Sponsor
- Novartis Pharmaceuticals (Industry)
- Enrollment
- 922 enrolled
- Conditions
- Chagas Disease; Heart Failure
- Interventions
- Sacubitril/valsartan; Enalapril
- Ages
- adults, older adults
- Registry
- NCT04023227
Full record on ClinicalTrials.gov
From the registry
The purpose of this study was to evaluate the effect of sacubitril/valsartan 200 mg BID compared with enalapril 10 mg BID, in addition to conventional heart failure (HF) treatment, in improving a hierarchical composite of cardiovascular (CV) events (i.e. CV death or the occurrence of first HF hospitalization) and causing a greater reduction in n terminal prohormone of brain natriuretic peptide (NT-proBNP, at Week 12 from Baseline) in participants with HF with reduced ejection fraction (HFrEF) caused by chronic Chagas' cardiomyopathy (CCC).
Primary outcomes
- Hierarchical Composite Endpoint Composed of Time to Cardiovascular (CV) Death, Time to First Heart Failure (HF) Hospitalization, and Relative Change in NT-proBNP From Baseline to Week 12
- Percentage of Participants Who Died From Cardiovascular Causes
- Percentage of Participants With First Hospitalization for Worsening Heart Failure
- Change From Baseline to Week 12 in NT-proBNP Levels
History
Results first posted
Last registry update
Study completion
Primary completion
Started
Registered