Gender-based Differences in the Outcome of Treatment With Aldosterone Antagonists in Patients With Heart Failure

NCT ID: NCT06233695

Last Updated: 2024-02-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-10-15
• Study Completion Date: 2023-12-01

Brief Summary

Heart failure (HF) is a major healthcare problem. In patients with Heart Failure with Reduced Ejection Fraction (HFrEF), aldosterone antagonists reduce mortality and hospitalization rate. Gender-related differences have been described in the regulation of 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 RAAS.

In this single-center prospective cohort, a total of 100 adult (≥ 18 years) ambulatory patients of both sexes with the diagnosis of HF with HFrEF (LVEF≤ 40%) and NYHA class II-IV under optimized medical therapy started an aldosterone antagonist are enrolled and followed-up for 6 months. Patients are categorized according to their apparent sexual gender into two groups: the male group and the female group.

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 with an apparent gender of female.

Potassium sparing diuretic

Intervention Type: DRUG

Starting Spironolactone or Eplerenone at the time of enrollment.

The Male Group

Patients with an apparent gender of male.

Potassium sparing diuretic

Intervention Type: DRUG

Starting Spironolactone or Eplerenone at the time of enrollment.

Interventions

Potassium sparing diuretic

Starting Spironolactone or Eplerenone at the time of enrollment.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• The diagnosis of heart failure with reduced ejection fraction HFrEF (LVEF≤ 40%) and New York Heart Association (NYHA) class II-IV under optimized medical therapy who are presented to the outpatient clinic and started an aldosterone antagonist at the time of enrollment.

Exclusion Criteria

• Pregnancy or breast-feeding.
• 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 transplant.
• Concomitant administration of strong CYP3A inhibitors.
• Concomitant administration of potassium supplements or potassium-sparing diuretics.
• Disorders of adrenal glands (Addison disease).
• Patients who used mineralocorticoid receptor antagonists in the last 2 weeks before enrollment.
• Patients with a history of mineralocorticoid receptor antagonists allergy or intolerance.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alexandria University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Salah Abdelkader, MSc

Role: PRINCIPAL_INVESTIGATOR

Cardiology Department, Faculty of Medicine, Alexandria University

Locations

Faculty of Medicine, Alexandria University Hospitals

Alexandria, , Egypt

Countries

Egypt

Other Identifiers

GBDAL-HF Trial

Identifier Type: -

Identifier Source: org_study_id