COmparing arNi and Ace For Improving Erectile Dysfunction in mEN With reduCed Ejection Fraction Heart Failure (CONFIDENCE-HF)

February 27, 2024 updated by: Novartis Pharmaceuticals

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

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.

Study Overview

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Bamberg, Germany, 96049
        • Novartis Investigative Site
      • Berlin, Germany, 10367
        • Novartis Investigative Site
      • Berlin, Germany, 10789
        • Novartis Investigative Site
      • Boehlen, Germany, 04564
        • Novartis Investigative Site
      • Buchholz in der Nordheide, Germany, 21244
        • Novartis Investigative Site
      • Frankfurt, Germany, 60594
        • Novartis Investigative Site
      • Jerichow, Germany, 39319
        • Novartis Investigative Site
      • Markkleeberg, Germany, 04416
        • Novartis Investigative Site
      • Nuremberg, Germany, 90402
        • Novartis Investigative Site
      • Rostock, Germany, 18107
        • Novartis Investigative Site
      • Ulm, Germany, 89077
        • Novartis Investigative Site
      • Wermsdorf, Germany, 04779
        • Novartis Investigative Site
    • Niedersachsen
      • Hannover, Niedersachsen, Germany, 30159
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LCZ696
LCZ696 200 mg (sacubitril/valsartan 97 mg/103 mg bid)
sacubitril/valsartan 200 mg = 97 mg/103 mg bid sacubitril/valsartan film-coated tablets
Placebo to LCZ696 200 mg = 97 mg/103 mg bid sacubitril/valsartan film-coated tablets
Active Comparator: Enalapril
Enalapril 10 mg
Placebo to Enalapril 10 mg film-coated tablets
Enalapril 10 mg film-coated tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Week 12 (3 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, Week 4, Week 12
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
Baseline, Week 4, Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 16, 2019

Primary Completion (Actual)

May 25, 2021

Study Completion (Actual)

May 25, 2021

Study Registration Dates

First Submitted

April 9, 2019

First Submitted That Met QC Criteria

April 15, 2019

First Posted (Actual)

April 17, 2019

Study Record Updates

Last Update Posted (Actual)

February 29, 2024

Last Update Submitted That Met QC Criteria

February 27, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Heart Failure

Clinical Trials on LCZ696

Subscribe