drugset / Trial / NCT04023227

Efficacy and Safety of Sacubitril/Valsartan Compared With Enalapril on Morbidity, Mortality, and NT-proBNP Change in Patients With CCC

NCT04023227

Phase 4 Completed 922 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupSingle-blindTreatment

Summary

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).

Timeline

Start
2019-12-10
Primary completion
2025-03-16
Completion
2025-03-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Enalapril Other / unclassified 10 mg Oral
Subject Sacubitril/valsartan Unknown 200 mg Oral