Adults 18 to 75, male only, with Heart Failure or Heart Failure, Systolic. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Erectile Function Score Using Index of Erectile Function (IIEF-15)Primary· Week 12 (3 months)
The International Index of Erectile Function (IIEF-15) was used to assess erectile function in male patients with chronic heart failure. The IIEF-15 is a patient self-reported assessment of erectile dysfunction (ED) and consists of 15 questions assessing different aspects associated with ED. The domain evaluating erectile function consists of items 1, 2, 3, 4, 5 \& 15 and its total score was used here. Total score range =1-30. Items 1-5 is 6-point Likert-type scale from '0' (= No sexual activity), '1' (=Almost never or never) to '5' (= Almost always or always). Items 15 is 5-point Likert-type
Group
Value
95% CI
LCZ696
15.1
± 2.15
Enalapril
12.2
± 2.00
Summary of Change From Baseline in Self-reported Frequency of Sexual Activity Per WeekSecondary· Baseline, Week 4, Week 12
Assessment of early-onset effect and end of study effect, regarding improvement in sexual activity, using patient's self-reported frequency of sexual activity per week. Patient was asked to complete a diary assessing sexual activity on a weekly basis
Week 4:
Group
Value
95% CI
LCZ696
-1.6
± 1.59
Enalapril
-1.1
± 1.97
Week 12:
Group
Value
95% CI
LCZ696
-1.4
± 3.13
Enalapril
-2.0
± 3.07
Summary of Change From Baseline in NT-proBNP LevelsSecondary· Baseline, Week 4, Week 12
Change in n-terminal prohormone of brain natriuretic peptide (NT-proBNP) levels compared to baseline assessed at Week 4 and Week 12
Week 4
Group
Value
95% CI
LCZ696
-369.00
-521.00 – -68.00
Enalapril
-43.50
-123.50 – 363.00
Week 12
Group
Value
95% CI
LCZ696
-208.50
-1469.00 – 416.50
Enalapril
-189.00
-394.00 – 10.00
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 1 month.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 29 February 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03917459.