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

Novartis

Status and phase: Completed; Phase 3

Conditions: Heart Failure, Systolic; Erectile Dysfunction; Heart Failure

Treatments: Drug: LCZ696 matching placebo; Drug: Enalapril; Drug: Enalapril matching placebo; Drug: LCZ696

Study type: Interventional

Funder types: Industry

Identifiers

NCT03917459

2018-000220-33 (EudraCT Number)

CLCZ696BDE03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 27 patients

Sex: Male

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

27 participants in 2 patient groups

LCZ696

Experimental group

Description:

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

Treatment:

Drug: LCZ696 matching placebo

Drug: LCZ696

Enalapril

Active Comparator group

Description:

Enalapril 10 mg

Treatment:

Drug: Enalapril

Drug: Enalapril matching placebo