- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03917459
COmparing arNi and Ace For Improving Erectile Dysfunction in mEN With reduCed Ejection Fraction Heart Failure (CONFIDENCE-HF)
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
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Bamberg, Germany, 96049
- Novartis Investigative Site
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Berlin, Germany, 10367
- Novartis Investigative Site
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Berlin, Germany, 10789
- Novartis Investigative Site
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Boehlen, Germany, 04564
- Novartis Investigative Site
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Buchholz in der Nordheide, Germany, 21244
- Novartis Investigative Site
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Frankfurt, Germany, 60594
- Novartis Investigative Site
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Jerichow, Germany, 39319
- Novartis Investigative Site
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Markkleeberg, Germany, 04416
- Novartis Investigative Site
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Nuremberg, Germany, 90402
- Novartis Investigative Site
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Rostock, Germany, 18107
- Novartis Investigative Site
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Ulm, Germany, 89077
- Novartis Investigative Site
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Wermsdorf, Germany, 04779
- Novartis Investigative Site
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Niedersachsen
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Hannover, Niedersachsen, Germany, 30159
- Novartis Investigative Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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
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Active Comparator: Enalapril
Enalapril 10 mg
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Placebo to Enalapril 10 mg film-coated tablets
Enalapril 10 mg film-coated tablets
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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)
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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
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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
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Baseline, Week 4, Week 12
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Summary of Change From Baseline in NT-proBNP Levels
Time Frame: Baseline, Week 4, Week 12
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Change in n-terminal prohormone of brain natriuretic peptide (NT-proBNP) levels compared to baseline assessed at Week 4 and Week 12
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Baseline, Week 4, Week 12
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Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Heart Diseases
- Cardiovascular Diseases
- Sexual Dysfunctions, Psychological
- Sexual Dysfunction, Physiological
- Heart Murmurs
- Urogenital Diseases
- Male Urogenital Diseases
- Genital Diseases, Male
- Genital Diseases
- Heart Failure
- Erectile Dysfunction
- Systolic Murmurs
- Heart Failure, Systolic
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Enzyme Inhibitors
- Protease Inhibitors
- Angiotensin Receptor Antagonists
- Angiotensin-Converting Enzyme Inhibitors
- Enalaprilat
- Enalapril
- Sacubitril and valsartan sodium hydrate drug combination
Other Study ID Numbers
- CLCZ696BDE03
- 2018-000220-33 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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
Studies a U.S. FDA-regulated device product
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.
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