NCT03917459

COmparing arNi and Ace For Improving Erectile Dysfunction in mEN With reduCed Ejection Fraction Heart Failure

A Randomized, Double-blind, Active-controlled Study to Assess the Effect of Sacubitril/Valsartan Compared With Enalapril to Improve Erectile Function in Patients With Heart Failure With Reduced Ejection Fraction and Erectile Dysfunction

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: Male
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to determine the effect of sacubitril/valsartan (LCZ696) vs. Enalapril on improvement in erectile function and ability in male patients with chronic heart failure with reduced ejection fraction and erectile dysfunction.

Detailed description

The purpose of this study was to evaluate the effect of sacubitril/valsartan in improving erectile function in male patients with chronic heart failure (NYHA II) and reduced ejection fraction (HFrEF) and erectile dysfunction (ED). Data from this study was intended to provide a thorough understanding of the impact of sacubitril/valsartan on male sexual function and therefore quality of life.

Conditions

• Heart Failure
• Heart Failure, Systolic
• Erectile Dysfunction

Interventions

Type	Name	Description
DRUG	LCZ696	sacubitril/valsartan 200 mg = 97 mg/103 mg bid sacubitril/valsartan film-coated tablets
DRUG	Enalapril matching placebo	Placebo to Enalapril 10 mg film-coated tablets
DRUG	Enalapril	Enalapril 10 mg film-coated tablets
DRUG	LCZ696 matching placebo	Placebo to LCZ696 200 mg = 97 mg/103 mg bid sacubitril/valsartan film-coated tablets

Timeline

• Start date: 2019-04-16
• Primary completion: 2021-05-25
• Completion: 2021-05-25
• First posted: 2019-04-17
• Last updated: 2024-02-29
• Results posted: 2024-01-08

Locations

13 sites across 1 country: Germany