NCT02554890

Comparison of Sacubitril/Valsartan Versus Enalapril on Effect on NT-proBNP in Patients Stabilized From an Acute Heart Failure Episode.

A Multicenter, Randomized, Double-blind, Double Dummy, Parallel Group, Active-controlled 8-week Study to Evaluate the Effect of Sacubitril/Valsartan (LCZ696) Versus Enalapril on Changes in NT-proBNP and Safety and Tolerability of In-hospital Initiation of LCZ696 Compared to Enalapril in HFrEF Patients Who Have Been Stabilized Following Hospitalization for Acute Decompensated Heart Failure (ADHF).

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 887 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to assess the effect of in-hospital initiation of sacubitril/valsartan (LCZ696) vs. enalapril on time averaged proportional change in NT-proBNP in patients who have been stabilized following hospitalization for acute decompensated heart failure (ADHF) and reduced ejection fraction (left ventricular ejection fraction (LVEF) ≤ 40%).

Conditions

• Acute Heart Failure

Interventions

Type	Name	Description
DRUG	sacubitril/valsartan (LCZ696)	sacubitril/valsartan (LCZ696) tablet with minimum dose 24/26 mg, maximum dose 97/103 mg twice daily administered orally.
DRUG	Enalapril	Enalapril tablet with minimum dose 2.5 mg, maximum dose 10 mg twice daily administered orally.
DRUG	sacubitril/valsartan (LCZ696) matching placebo	matching placebo of sacubitril/valsartan (LCZ696) tablet with minimum dose 24/26 mg, maximum dose 97/103 mg twice daily administered orally.
DRUG	enalapril matching placebo	enalapril matching placebo tablet with minimum dose 2.5 mg, maximum dose 10 mg twice daily administered orally.

Timeline

• Start date: 2016-04-29
• Primary completion: 2018-06-29
• Completion: 2018-07-24
• First posted: 2015-09-18
• Last updated: 2021-01-05
• Results posted: 2019-09-24

Locations

123 sites across 1 country: United States