Heart FailurePhase 3CONFIDENCE-HFNCT03917459

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

A Phase 3 study testing LCZ696 and Enalapril in people with Heart Failure and Heart Failure, Systolic, run by Novartis Pharmaceuticals at 13 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 75 years, men only
Conditions the study is for: Heart Failure, Heart Failure, Systolic, Erectile Dysfunction
What is being tested?: LCZ696 and Enalapril
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 27 participants
Where: 13 sitesGermany
Study dates: 16 Apr 2019to 25 May 2021
Phase: Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

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Penile anatomical defects and Peyronie's disease
Diabetes mellitus Type I or insulin-dependent Type II
Known prostate cancer

Trial locations and contacts

13 sites in 1 country.

City, postcode or hospital

13 sites in 1 country

Germany13 sites

Novartis Investigative Site
Bamberg, 96049
Novartis Investigative Site
Berlin, 10367
Novartis Investigative Site
Berlin, 10789
Novartis Investigative Site
Böhlen, 04564
Novartis Investigative Site
Buchholz in der Nordheide, 21244
Novartis Investigative Site
Frankfurt, 60594
Novartis Investigative Site
Hanover, Lower Saxony, 30159
Novartis Investigative Site
Jerichow, 39319
Novartis Investigative Site
Markkleeberg, 04416
Novartis Investigative Site
Nuremberg, 90402
Novartis Investigative Site
Rostock, 18107
Novartis Investigative Site
Ulm, 89077
Novartis Investigative Site
Wermsdorf, 04779

Other trials in Germany

About this study

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

Read the 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.

Conditions: Heart Failure, Heart Failure, Systolic, Erectile Dysfunction
Being tested: LCZ696, Enalapril matching placebo, Enalapril, LCZ696 matching placebo
Keywords: heart failure, systolic heart failure, heart failure with reduced ejection fraction, erectile dysfunction, Enalapril, Enalaprilat, LCZ696, Sacubitril/valsartan
Medical subject headings: Heart Failure, Heart Failure, Systolic, Erectile Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LCZ696Drug
sacubitril/valsartan 200 mg = 97 mg/103 mg bid sacubitril/valsartan film-coated tablets
Enalapril matching placeboDrug
Placebo to Enalapril 10 mg film-coated tablets
EnalaprilDrug
Enalapril 10 mg film-coated tablets
LCZ696 matching placeboDrug
Placebo to LCZ696 200 mg = 97 mg/103 mg bid sacubitril/valsartan film-coated tablets

Study groups in NCT03917459
Study group	Role	What they receive
LCZ696	Experimental	LCZ696 200 mg (sacubitril/valsartan 97 mg/103 mg bid) Receives: Drug: LCZ696; Drug: LCZ696 matching placebo
Enalapril	Active comparator	Enalapril 10 mg Receives: Drug: Enalapril matching placebo; Drug: Enalapril

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: Week 12 (3 months)

Secondary outcomes (2)

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
Measured: Baseline, Week 4, Week 12
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
Measured: Baseline, Week 4, Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Apr 201925 May 2021

First posted17 Apr 2019
Study start16 Apr 2019
Primary completion25 May 2021
Study completion25 May 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Heart FailureStudies of the same condition, open and under way.
More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03917459
Sponsor's protocol ID: CLCZ696BDE03
Other IDs: 2018-000220-33, 2018
Acronym: CONFIDENCE-HF
Status last verified: Feb 2024
First submitted: 9 Apr 2019
Last updated: 29 Feb 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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