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

NCT06641284 | Completed

• 1 other identifier: 2460
• Study Type: observational
• Target: 509
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Heart Failure; Gender; Spironolactone

Outcome Measures

Primary Outcomes (1)

• HF Hospitalization

  The event of hospitalization due to heart failure.

  6 months after enrollment

Secondary Outcomes (2)

• Hospitalization

  6 months after enrollment

• All-cause mortality

  6 months after enrollment

Study Arms (2)

The Female Group

Patients identified themselves as females (Apparent gender)

Drug: Spironolactone

The Male Group

Patients identified themselves as males (Apparent gender)

Drug: Spironolactone

Interventions

Spironolactone DRUG

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

The Female Group; The Male Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ahmad Abdullah Salawi: lead

Study Sites (1)

King Fahd Central Hospital

Al ‘Usaylah, Saudi Arabia

Location

MeSH Terms

Conditions

Heart Failure; Coitus

Interventions

Spironolactone

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Sexual Behavior; Behavior

Intervention Hierarchy (Ancestors)

Lactones; Organic Chemicals; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Pharmaceutics

Study Record Dates

• First Submitted: October 11, 2024
• First Posted: October 15, 2024
• Study Start: October 1, 2023
• Primary Completion: October 15, 2024
• Study Completion: October 15, 2024
• Last Updated: March 24, 2025

Record last verified: 2025-03

Locations

SA (1)