Trials / Completed
CompletedNCT06641284
Gender-Based Differences in Heart Failure Hospitalizations Among Patients With Heart Failure Treated With Spironolactone
Gender-Based Differences in Heart Failure Hospitalizations Among Patients With Heart Failure With Reduced Ejection Fraction Treated With Spironolactone: A Prospective Cohort Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 509 (actual)
- Sponsor
- Ahmad Abdullah Salawi · Other Government
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Heart Failure
- Heart Failure With Reduced Ejection Fraction
- Heart Failure NYHA Class II
- Heart Failure NYHA Class III
- Heart Failure NYHA Class IV
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Spironolactone | All patients will receive Spironolactone as a part of their GDMT for Heart Failure |
Timeline
- Start date
- 2023-10-01
- Primary completion
- 2024-10-15
- Completion
- 2024-10-15
- First posted
- 2024-10-15
- Last updated
- 2025-03-24
Locations
1 site across 1 country: Saudi Arabia
Source: ClinicalTrials.gov record NCT06641284. Inclusion in this directory is not an endorsement.