An observational study in Heart Failure, Heart Failure With Reduced Ejection Fraction and Heart Failure NYHA Class II, sponsored by Ahmad Abdullah Salawi. Completed at 1 site in Saudi Arabia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-24.
Sponsored by Ahmad Abdullah Salawi · Observational
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.
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.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 509 is above the median of 200 across 1,679 observational studies indexed under Heart Failure.
Browse Heart Failure studies →This is the only study on the registry with Ahmad Abdullah Salawi as lead sponsor.
Counted across the registry records on this site, refreshed daily.
adult (≥ 18 years) ambulatory patients of both sexes with a diagnosis of HFrEF (LVEF≤ 40%) and NYHA class II-IV under optimized medical therapy who are presented to the outpatient clinic and started spironolactone at the time of enrollment.
Exclusion Criteria:
Patients identified themselves as females (Apparent gender)
Drug: Spironolactone
Patients identified themselves as males (Apparent gender)
Drug: Spironolactone
All patients will receive Spironolactone as a part of their GDMT for Heart Failure
HF Hospitalization
The event of hospitalization due to heart failure.
Time frame: 6 months after enrollment
Hospitalization
The event of hospitalization due to any cause.
Time frame: 6 months after enrollment
All-cause mortality
The event of mortality due to any cause.
Time frame: 6 months after enrollment
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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