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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Heart Failure, Heart Failure, Systolic, Erectile Dysfunction

Intervention / Treatment
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* Drug: LCZ696
* Drug: Enalapril matching placebo
* Drug: Enalapril
* Drug: LCZ696 matching placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LCZ696<br> | Drug: LCZ696<br>* 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<br>Drug: Enalapril matching placebo<br>* Placebo to Enalapril 2.5 mg, 5 mg and 10 mg film-coated tablets<br>|
| Active Comparator: Enalapril<br> | Drug: Enalapril<br>* Enalapril 2.5 mg, 5 mg and 10 mg film-coated tablets<br>Drug: LCZ696 matching placebo<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Erectile function score at 3 months | The questionnaire International Index of Erectile Function (IIEF-15) is used to assess erectile function | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported frequency of sexual activity per month at months 1 and 3 | Patient is asked to complete a diary assessing sexual activity on a weekly basis | 1 months and 3 months | 
| NT-proBNP levels at months 1 and 3 | Change in NT-proBNP compared to baseline will be assessed at month 1 and month 3 | 1 month and 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heart failure, systolic heart failure, heart failure with reduced ejection fraction, erectile dysfunction, Enalapril, Enalaprilat, LCZ696, Sacubitril/valsartan