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

NCT03917459 | Completed Phase 3 Results

• 2 other identifiers: CLCZ696BDE032018-000220-33
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 13

Brief 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.

Conditions

Heart Failure; Heart Failure, Systolic; Erectile Dysfunction

Keywords

heart failure; systolic heart failure; heart failure with reduced ejection fraction; erectile dysfunction; Enalapril; Enalaprilat; LCZ696; Sacubitril/valsartan

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Summary of Change From Baseline in Self-reported Frequency of Sexual Activity Per Week

  Baseline, Week 4, Week 12

• Summary of Change From Baseline in NT-proBNP Levels

  Baseline, Week 4, Week 12

Study Arms (2)

LCZ696

EXPERIMENTAL

LCZ696 200 mg (sacubitril/valsartan 97 mg/103 mg bid)

Drug: LCZ696; Drug: LCZ696 matching placebo

Enalapril

ACTIVE COMPARATOR

Enalapril 10 mg

Drug: Enalapril matching placebo; Drug: Enalapril

Interventions

LCZ696 DRUG

sacubitril/valsartan 200 mg = 97 mg/103 mg bid sacubitril/valsartan film-coated tablets

LCZ696

Enalapril matching placebo DRUG

Placebo to Enalapril 10 mg film-coated tablets

Enalapril

Enalapril DRUG

Enalapril 10 mg film-coated tablets

Enalapril

LCZ696 matching placebo DRUG

Placebo to LCZ696 200 mg = 97 mg/103 mg bid sacubitril/valsartan film-coated tablets

LCZ696

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (13)

Novartis Investigative Site

Hanover, Lower Saxony, 30159, Germany

Location

Novartis Investigative Site

Bamberg, 96049, Germany

Location

Novartis Investigative Site

Berlin, 10367, Germany

Location

Novartis Investigative Site

Berlin, 10789, Germany

Location

Novartis Investigative Site

Böhlen, 04564, Germany

Location

Novartis Investigative Site

Buchholz in der Nordheide, 21244, Germany

Location

Novartis Investigative Site

Frankfurt, 60594, Germany

Location

Novartis Investigative Site

Jerichow, 39319, Germany

Location

Novartis Investigative Site

Markkleeberg, 04416, Germany

Location

Novartis Investigative Site

Nuremberg, 90402, Germany

Location

Novartis Investigative Site

Rostock, 18107, Germany

Location

Novartis Investigative Site

Ulm, 89077, Germany

Location

Novartis Investigative Site

Wermsdorf, 04779, Germany

Location

Related Links

• Plain Language Trial Summary

MeSH Terms

Conditions

Heart Failure; Heart Failure, Systolic; Erectile Dysfunction

Interventions

sacubitril and valsartan sodium hydrate drug combination; Enalapril

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Dipeptides; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

Novartis.email@novartis.com

862-778-8300

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2019
• First Posted: April 17, 2019
• Study Start: April 16, 2019
• Primary Completion: May 25, 2021
• Study Completion: May 25, 2021
• Last Updated: February 29, 2024
• Results First Posted: January 8, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share

Locations

DE (13)