Ignite Creation Date:
2025-12-24 @ 2:39 PM
Ignite Modification Date:
2026-01-12 @ 4:54 AM
Study NCT ID:
NCT03917459
Status:
COMPLETED
Last Update Posted:
2024-02-29
First Post:
2019-04-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
COmparing arNi and Ace For Improving Erectile Dysfunction in mEN With reduCed Ejection Fraction Heart Failure
Sponsor:
Novartis Pharmaceuticals
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CONFIDENCE-HF
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.
Detailed 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2018-000220-33 | EUDRACT_NUMBER | None | View |