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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03917459
Other study ID # CLCZ696BDE03
Secondary ID 2018-000220-33
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


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
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