Phase 3
N=27
COmparing arNi and Ace For Improving Erectile Dysfunction in mEN With reduCed Ejection Fraction Heart Failure
Heart Failure · Heart Failure, Systolic · Erectile Dysfunction
Bottom Line
View on ClinicalTrials.gov: NCT03917459 ↗Enrolled (actual)
27
Serious AEs
7.4%
Results posted
Jan 2024
Primary outcome: Primary: Erectile Function Score Using Index of Erectile Function (IIEF-15) — 15.1; 12.2 Scores on a scale — p=0.3432
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- LCZ696 (Drug); Enalapril matching placebo (Drug); Enalapril (Drug); LCZ696 matching placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- May 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Erectile Function Score Using Index of Erectile Function (IIEF-15) |
15.1; 12.2 | 0.3432 |
| SECONDARY Summary of Change From Baseline in Self-reported Frequency of Sexual Activity Per Week |
-1.6; -1.1; -1.4; -2.0 | — |
| SECONDARY Summary of Change From Baseline in NT-proBNP Levels |
-369.00; -43.50; -208.50; -189.00 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03917459). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.