Clinical trial NCT03917459: COmparing arNi and Ace For Improving Erectile Dysfunction in mEN With reduCed Ejection Fraction Heart Failure
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Heart Failure
Heart Failure, Systolic
Erectile Dysfunction
Keywords: heart failure
systolic heart failure
heart failure with reduced ejection fraction
erectile dysfunction
Enalapril
Enalaprilat
LCZ696
Sacubitril/valsartan
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2019-04-17
Enrollment: 27
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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

Primary outcomes:
measure: Erectile Function Score Using Index of Erectile Function (IIEF-15)
timeFrame: Week 12 (3 months)
Secondary outcomes:
measure: Summary of Change From Baseline in Self-reported Frequency of Sexual Activity Per Week
timeFrame: Baseline, Week 4, Week 12
measure: Summary of Change From Baseline in NT-proBNP Levels
timeFrame: Baseline, Week 4, Week 12
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Novartis Investigative Site
state: Niedersachsen
city: Bamberg
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Boehlen
country: Germany
facility: Novartis Investigative Site
city: Buchholz in der Nordheide
country: Germany
facility: Novartis Investigative Site
city: Frankfurt
country: Germany
facility: Novartis Investigative Site
city: Jerichow
country: Germany
facility: Novartis Investigative Site
city: Markkleeberg
country: Germany
facility: Novartis Investigative Site
city: Nuremberg
country: Germany
facility: Novartis Investigative Site
city: Rostock
country: Germany
facility: Novartis Investigative Site
city: Ulm
country: Germany
facility: Novartis Investigative Site
city: Wermsdorf
country: Germany
facility: Novartis Investigative Site
Study officials:
References: