Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06641284
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-11
Brief Title:
Gender-Based Differences in Heart Failure Hospitalizations Among Patients With Heart Failure Treated With Spironolactone
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Gender-Based Differences in Heart Failure Hospitalizations Among Patients With Heart Failure With Reduced Ejection Fraction Treated With Spironolactone A Prospective Cohort Study
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Aldosterone antagonists or mineralocorticoid receptor antagonists MRAs are used as therapeutic agents for the management of HF with reduced ejection fraction HFrEF Gender-related differences have been described in the regulation of the 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 the RAAS even though studies have suggested that androgens may increase the RAAS pathway There are conflicting results because many clinical trials were not specifically designed to investigate gender differences
Detailed Description:
The RALES trial investigated the effect of spironolactone on symptomatic HF patients without any difference in treatment benefits between both genders However only 30 of the patients enrolled were females Another trial investigated the gender-based differences in the treatment of HFpEF patients with spironolactone The results showed no significant sex differences in clinical endpoints but a substantial reduction in all-cause mortality was associated with spironolactone use in females but not in males The utilization of HF pharmacotherapy has been controversial given recent discoveries presented by the PARAGON-HF trial
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None