Patients with heart failure with reduced ejection fraction (HFrEF) and erectile dysfunction (ED) MedDRA version: 20.0 Level: LLT Classification code 10008502 Term: CHF System Organ Class: 100000004849
Conditions
Sponsors
Novartis Pharma GmbH
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Patients must give written informed consent before any assessment is performed and must be willing and capable to comply with all study procedures. 2. Male Outpatients = 18 and = 75 years of age 3. Patients with a diagnosis of CHF NYHA class II and reduced ejection fraction ( 7 and = 21 IIEF units) at Visit 1 and Visit 2 7. No usage of any available drug for erectile dysfunction (e.g. sildenafil, tadalafil) for at least 2 weeks prior to Visit 1 and 4 weeks prior to Visit 2 8. Patients must be on an ACEI or an ARB at a stable dose for at least 2 weeks prior to Visit 1 and 4 weeks prior to Visit 2 9. Patients must be treated with a stable dose of bisoprolol/metoprolol, unless the use of ß-blockers is contraindicated or not tolerated (reason should be documented) for at least 2 weeks prior to Visit 1 and 4 weeks prior to Visit 2 (ß-blockers other than bisoprolol/metoprolol are not allowed per protocol) 10. Patients must be literate in German Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Use of other investigational drugs during the study and within 30 days or 5 half-lives, whichever is longer before enrolment and at enrolment 2. 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 3. Previous history of intolerance to recommended target doses of ACEIs or ARBs 4. Known history of angioedema 5. Requirement of treatment with a dual RAAS blockade, e.g. a treatment with both, ACEIs and ARBs or concomitant treatment with aliskiren 6. Current acute decompensated HF (exacerbation of chronic HF manifested by signs and symptoms that may require intravenous therapy) 7. Symptomatic hypotension and/or a systolic blood pressure (SBP) =100 mm Hg at Visit 1 (Screening) or Visit 2 (Randomization) 8. Estimated glomerular filtration rate (eGFR) 5.2mmol/L at Visit 1 (Screening) or Visit 2 (Randomization) 10. Acute coronary syndrome, stroke, transient ischemic attack, cardiac, carotid or other major CV surgery, percutaneous coronary intervention (PCI) or carotid angioplasty within the 3 months prior to Visit 1 Other protocol defined exclusion criteria may apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Demonstrate the superiority of sacubitril/valsartan compared to enalapril regarding improvement in erectile function and ability in male patients with chronic heart failure and erectile dysfunction using the questionnaire International Index of Erectile Function (IIEF-15) at the end of the study;Secondary Objective: Assess the early-onset effect as well as the effect at the end of the study of sacubitril/valsartan versus enalapril regarding improvement in sexual activity Assess the early-onset effect as well as the effect at the end of the study of sacubitril/valsartan versus enalapril regarding NTproBNP levels;Primary end point(s): Erectile function score at 3 months ;Timepoint(s) of evaluation of this end point: 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Self-reported frequency of sexual activity per month at months 1 and 3 • NT-proBNP levels at months 1 and 3;Timepoint(s) of evaluation of this end point: 1 and 3 months | — |
Countries
Germany
Contacts
Public ContactMedizinischer Infoservice (MCC)
Novartis Pharma GmbH
Outcome results
None listed