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

ClinicalTrials.gov Identifier: NCT03917459

Novartis Reference Number: CLCZ696BDE03

Last Update: Mar 26, 2021

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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

Condition

Heart Failure

Heart Failure, Systolic

Erectile Dysfunction

Phase

Phase 3

Overall status

Recruiting

Enrollment count

200 participants

Start date

Apr 16, 2019

Completion date

Mar 16, 2022

Gender

Male

Age(s)

18 Years - 75 Years (Adult, Older Adult)

Interventions

Drug

LCZ696

LCZ696 50 mg = 24 mg/26 mg bid sacubitril/valsartan; 100 mg= 49 mg/51 mg bid sacubitril/valsartan or 200 mg = 97 mg/103 mg bid sacubitril/valsartan film-coated tablets

Drug

Enalapril matching placebo

Placebo to Enalapril 2.5 mg, 5 mg and 10 mg film-coated tablets

Drug

Enalapril

Enalapril 2.5 mg, 5 mg and 10 mg film-coated tablets

Drug

LCZ696 matching placebo

Placebo to LCZ696 50 mg = 24 mg/26 mg bid sacubitril/valsartan; 100 mg= 49 mg/51 mg bid sacubitril/valsartan or 200 mg = 97 mg/103 mg bid sacubitril/valsartan film-coated tabletsLCZ696 50 mg, 100 mg and 200 mg

Eligibility Criteria

Key Inclusion Criteria:

Patients with a diagnosis of chronic heart failure (NYHA class II) and reduced ejection fraction (LVEF < 40%)
Patients must be living in a stable and sexually active heterosexual partnership for at least 6 months prior study start
Patients must have a mild to moderate erectile dysfunction (determined by using the IIEF-5 questionnaire)
Patients must be on an ACEI or an ARB at a stable dose for at least 4 weeks prior study start
Patients must be literate in German

Key Exclusion Criteria:

History of hypersensitivity to any of the study drugs or its excipients or to drugs of similar chemical classes, ACEIs, ARBs or NEP inhibitors, as well as known or suspected contraindications to the study drugs
Previous history of intolerance to recommended target doses of ACEIs or ARBs
Known history of angioedema
Current acute decompensated HF (exacerbation of chronic HF manifested by signs and symptoms that may require intravenous therapy)
Symptomatic hypotension
Impaired renal function
Penile anatomical defects and Peyronie's disease
Diabetes mellitus Type I or insulin-dependent Type II
Known prostate cancer

Other protocol-defined inclusion/exclusion criteria may apply.