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Completed

NCT Number: NCT03917459

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

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Erectile Dysfunction Genital Diseases Genital Diseases, Male Heart Diseases Heart Failure, Systolic Male Urogenital Diseases Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

18 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigative Site, Hanover, Lower Saxony, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LCZ696

Drug

sacubitril/valsartan 200 mg = 97 mg/103 mg bid sacubitril/valsartan film-coated tablets

enalapril matching placebo

Drug

Placebo to Enalapril 10 mg film-coated tablets

Enalapril

Drug

Enalapril 10 mg film-coated tablets

LCZ696 matching placebo

Drug

Placebo to LCZ696 200 mg = 97 mg/103 mg bid sacubitril/valsartan film-coated tablets

Primary outcomes

  1. Erectile Function Score Using Index of Erectile Function (IIEF-15)

    Time frame: 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 scale from '1' (= very low) to '5 '(= very high). Higher score indicates better outcome

Secondary outcomes

  1. Summary of Change From Baseline in Self-reported Frequency of Sexual Activity Per Week

    Time frame: 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

  2. Summary of Change From Baseline in NT-proBNP Levels

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Acronym: CONFIDENCE-HF

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 17, 2019
Registry last updated
Feb 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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