NCT04023227

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

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).

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 918 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is 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 CCC.

Conditions

• Chagas Disease
• Heart Failure

Interventions

Type	Name	Description
DRUG	Sacubitril/valsartan	50 (24/26) mg, 100 (49/51) mg and 200 (97/103) mg will be available for dose adjustments.
DRUG	Enalapril	5 mg and 10 mg will be available for dose adjustments.

Timeline

• Start date: 2019-12-10
• Primary completion: 2025-03-16
• Completion: 2025-03-31
• First posted: 2019-07-17
• Last updated: 2025-11-19

Locations

79 sites across 4 countries: Argentina, Brazil, Colombia, Mexico