At a glance
ClinicalIndex Comparison Record- ✓NYHA Class III chronic heart failure with reduced ejection fraction (LVEF ≤40%)
- ✓Reduced exercise capacity with VO2peak ≤18 ml/min/kg
- ✓Stable ACEI or ARB therapy at enalapril ≥10 mg/day (or equivalent) for ≥4 weeks prior to screening
- ✕Hypersensitivity or allergy to study drugs, ACEIs, ARBs, or NEP inhibitors
- ✕Previous intolerance to recommended target doses of ACEIs or ARBs
- ✕Known history of angioedema
- ✕Requirement for dual ACEI and ARB therapy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-blind, Active-controlled Study to Assess the Effect of LCZ696 Compared With Enalapril to Improve Exercise Capacity in Patients With Heart Failure With Reduced Ejection Fraction (HFrEF).
In Brief
A Phase 4 clinical trial evaluating LCZ696, Enalapril, and 2 other interventions for Chronic Heart Failure With Reduced Ejection Fraction. Completed, enrolled 201 participants across 34 sites.
Detailed Summary
The purpose of the study was to determine the effect of LCZ696 vs. enalapril on improvement of exercise capacity in patients with chronic heart failure with reduced ejection fraction.
Study Details
Timeline
Interventions
LCZ696 100 mg bid for 2 weeks followed by LCZ696 200 mg bid for 10 weeks. Treatment was administered as oral tablets.
Enalapril 5 mg bid for 2 weeks followed by enalapril 10 mg bid for 10 weeks. Treatment was administered as oral tablets. Patients who prior Screening were at a stable daily dose of enalapril above 10 mg per day (or corresponding doses of other ACEI/ARB) started the study at a dose of enalapril 10 mg bid.
Patients randomized to LCZ696 arm also received placebo matching enalapril (enalapril 0 mg tablets) to ensure the blinding during the entire course of the study.
Patients randomized to enalapril arm also received placebo matching LCZ696 (LCZ696 0 mg tablets) to ensure the blinding during the entire course of the study.