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

Heart Failure Clinical Trial

— CONFIDENCE-HF  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03917459
• Other study ID #: CLCZ696BDE03
• Secondary ID: 2018-000220-33
• Status: Completed
• Phase: Phase 3
• Start date: April 16, 2019
• Est. completion date: May 25, 2021

Study information

• Verified date: February 2024
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: May 25, 2021
• Est. primary completion date: May 25, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Erectile Dysfunction
• Heart Failure
• Heart Failure, Systolic
• Systolic Murmurs

Intervention

Drug:
• LCZ696
sacubitril/valsartan 200 mg = 97 mg/103 mg bid sacubitril/valsartan film-coated tablets
• Enalapril matching placebo
Placebo to Enalapril 10 mg film-coated tablets
• Enalapril
Enalapril 10 mg film-coated tablets
• LCZ696 matching placebo
Placebo to LCZ696 200 mg = 97 mg/103 mg bid sacubitril/valsartan film-coated tablets

Locations

Country	Name	City	State
Germany	Novartis Investigative Site	Bamberg
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Boehlen
Germany	Novartis Investigative Site	Buchholz in der Nordheide
Germany	Novartis Investigative Site	Frankfurt
Germany	Novartis Investigative Site	Hannover	Niedersachsen
Germany	Novartis Investigative Site	Jerichow
Germany	Novartis Investigative Site	Markkleeberg
Germany	Novartis Investigative Site	Nuremberg
Germany	Novartis Investigative Site	Rostock
Germany	Novartis Investigative Site	Ulm
Germany	Novartis Investigative Site	Wermsdorf

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Erectile Function Score Using Index of Erectile Function (IIEF-15)	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	Week 12 (3 months)
Secondary	Summary of Change From Baseline in Self-reported Frequency of Sexual Activity Per Week	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	Baseline, Week 4, Week 12
Secondary	Summary of Change From Baseline in NT-proBNP Levels	Change in n-terminal prohormone of brain natriuretic peptide (NT-proBNP) levels compared to baseline assessed at Week 4 and Week 12	Baseline, Week 4, Week 12

External Links

•   Plain Language Trial Summary