Viewing Study NCT06233695



Ignite Creation Date: 2024-05-06 @ 8:04 PM
Last Modification Date: 2024-10-26 @ 3:19 PM
Study NCT ID: NCT06233695
Status: COMPLETED
Last Update Posted: 2024-02-26
First Post: 2024-01-13

Brief Title: Gender-based Differences in the Outcome of Treatment With Aldosterone Antagonists in Patients With Heart Failure
Sponsor: Alexandria University
Organization: Alexandria University

Study Overview

Official Title: The Gender-Based Differences in the Outcome of Treatment by Aldosterone Antagonists in Patients With Heart Failure
Status: COMPLETED
Status Verified Date: 2024-01
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: GBDAL-HF
Brief Summary: Heart failure HF is a major healthcare problem In patients with Heart Failure with Reduced Ejection Fraction HFrEF aldosterone antagonists reduce mortality and hospitalization rate Gender-related differences have been described in the regulation of renin angiotensin aldosterone system RAAS which is at the core of the pathophysiology of HF Regarding gender-related differences in the use of MRAs less is known about the effects of androgens on RAAS

In this single-center prospective cohort a total of 100 adult 18 years ambulatory patients of both sexes with the diagnosis of HF with HFrEF LVEF 40 and NYHA class II-IV under optimized medical therapy started an aldosterone antagonist are enrolled and followed-up for 6 months Patients are categorized according to their apparent sexual gender into two groups the male group and the female group
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: True
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: False
Is an FDA AA801 Violation?: None