Gender-Based Differences in Heart Failure Hospitalizations Among Patients With Heart Failure Treated With Spironolactone

NCT ID: NCT06641284

Last Updated: 2025-03-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 509 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2024-10-15

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.

Conditions

Heart Failure; Heart Failure With Reduced Ejection Fraction; Heart Failure NYHA Class II; Heart Failure NYHA Class III; Heart Failure NYHA Class IV

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

The Female Group

Patients identified themselves as females (Apparent gender)

Spironolactone

Intervention Type: DRUG

All patients will receive Spironolactone as a part of their GDMT for Heart Failure

The Male Group

Patients identified themselves as males (Apparent gender)

Spironolactone

Intervention Type: DRUG

All patients will receive Spironolactone as a part of their GDMT for Heart Failure

Interventions

Spironolactone

All patients will receive Spironolactone as a part of their GDMT for Heart Failure

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• All 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

• Pregnancy or breastfeeding
• Serum creatinine > 2.5 mg/dL (221 µmol/L) in males and > 2 mg/dL (177 µmol/L) in women (or estimated glomerular filtration rate (eGFR) ≤ 30 mL/minute/1.73 m2)
• Hyperkalemia (serum potassium level > 5 mEq/L)
• Renal transplantation
• Concomitant administration of potent CYP3A inhibitors
• Concomitant administration of potassium supplements or potassium-sparing diuretics
• Disorders of the adrenal glands (such as Addison disease).
• Patients who used MRA in the last 2 weeks before enrollment.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ahmad Abdullah Salawi

OTHER_GOV

Sponsor Role: lead

Responsible Party

Ahmad Abdullah Salawi

Associate Professor of Pharmaceutics

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

King Fahd Central Hospital

Al ‘Usaylah, , Saudi Arabia

Countries

Saudi Arabia

Other Identifiers

2460

Identifier Type: -

Identifier Source: org_study_id