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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT03917459

Collaborator

(none)

Enrollment

Locations

Arms

25.3

Actual Duration (Months)

2.1

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the effect of LCZ696 vs. Enalapril on improvement in erectile function and ability in male patients with chronic heart failure with reduced ejection fraction and erectile dysfunction

Condition or Disease	Intervention/Treatment	Phase
Heart Failure Heart Failure, Systolic Erectile Dysfunction	Drug: LCZ696 Drug: Enalapril matching placebo Drug: Enalapril Drug: LCZ696 matching placebo	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

27 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Apr 16, 2019

Actual Primary Completion Date :

May 25, 2021

Actual Study Completion Date :

May 25, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LCZ696	Drug: LCZ696 LCZ696 50 mg = 24 mg/26 mg bid sacubitril/valsartan; 100 mg= 49 mg/51 mg bid sacubitril/valsartan or 200 mg = 97 mg/103 mg bid sacubitril/valsartan film-coated tablets Drug: Enalapril matching placebo Placebo to Enalapril 2.5 mg, 5 mg and 10 mg film-coated tablets
Active Comparator: Enalapril	Drug: Enalapril Enalapril 2.5 mg, 5 mg and 10 mg film-coated tablets Drug: LCZ696 matching placebo Placebo to LCZ696 50 mg = 24 mg/26 mg bid sacubitril/valsartan; 100 mg= 49 mg/51 mg bid sacubitril/valsartan or 200 mg = 97 mg/103 mg bid sacubitril/valsartan film-coated tabletsLCZ696 50 mg, 100 mg and 200 mg

Arm

Intervention/Treatment

Experimental: LCZ696

Drug: LCZ696

LCZ696 50 mg = 24 mg/26 mg bid sacubitril/valsartan; 100 mg= 49 mg/51 mg bid sacubitril/valsartan or 200 mg = 97 mg/103 mg bid sacubitril/valsartan film-coated tablets

Drug: Enalapril matching placebo

Placebo to Enalapril 2.5 mg, 5 mg and 10 mg film-coated tablets

Active Comparator: Enalapril

Drug: Enalapril

Enalapril 2.5 mg, 5 mg and 10 mg film-coated tablets

Drug: LCZ696 matching placebo

Placebo to LCZ696 50 mg = 24 mg/26 mg bid sacubitril/valsartan; 100 mg= 49 mg/51 mg bid sacubitril/valsartan or 200 mg = 97 mg/103 mg bid sacubitril/valsartan film-coated tabletsLCZ696 50 mg, 100 mg and 200 mg

Outcome Measures

Primary Outcome Measures

Erectile function score at 3 months [3 months]
The questionnaire International Index of Erectile Function (IIEF-15) is used to assess erectile function

Secondary Outcome Measures

Self-reported frequency of sexual activity per month at months 1 and 3 [1 months and 3 months]
Patient is asked to complete a diary assessing sexual activity on a weekly basis
NT-proBNP levels at months 1 and 3 [1 month and 3 months]
Change in NT-proBNP compared to baseline will be assessed at month 1 and month 3

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigative Site	Hannover	Niedersachsen	Germany	30159
2	Novartis Investigative Site	Bamberg		Germany	96049
3	Novartis Investigative Site	Berlin		Germany	10367
4	Novartis Investigative Site	Berlin		Germany	10789
5	Novartis Investigative Site	Boehlen		Germany	04564
6	Novartis Investigative Site	Buchholz in der Nordheide		Germany	21244
7	Novartis Investigative Site	Frankfurt		Germany	60594
8	Novartis Investigative Site	Jerichow		Germany	39319
9	Novartis Investigative Site	Markkleeberg		Germany	04416
10	Novartis Investigative Site	Nuremberg		Germany	90402
11	Novartis Investigative Site	Rostock		Germany	18107
12	Novartis Investigative Site	Ulm		Germany	89077
13	Novartis Investigative Site	Wermsdorf		Germany	04779