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

• Status: Completed
• Trial end date: 2021-05-25
• Target enrollment: 0
• Participant gender: Male

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Enalapril; Enalaprilat; LCZ 696; Sacubitril and valsartan sodium hydrate drug combination; Valsartan

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

Other protocol-defined inclusion/exclusion criteria may apply.