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

Completed

• Conditions: Heart Failure; Heart Failure With Reduced Ejection Fraction; Heart Failure NYHA Class IV; Heart Failure NYHA Class II; Heart Failure NYHA Class III
• Interventions: Drug: Potassium sparing diuretic

• Registration Number: NCT06233695
• Lead Sponsor: Alexandria University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-15
• Primary Completion: 2023-07-15
• Study Completion: 2023-12-01
• Status Verified: 2024-01
• Study First Submitted: 2024-01-13
• Study First Submitted QC: 2024-01-28
• Study First Posted: 2024-01-31
• Last Update Submitted: 2024-02-23
• Last Update Posted: 2024-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
The Female Group	Potassium sparing diuretic	Patients with an apparent gender of female.
The Male Group	Potassium sparing diuretic	Patients with an apparent gender of male.

Primary Outcome Measures

Name	Time	Method
Heart failure hospitalization	6 months after enrollment	The incidence of Hospitalization due to heart failure
Acute myocardial infarction	6 months after enrollment	The incidence of acute myocardial infarction
Percentage of patients who discontinued mineralocorticoid receptor antagonist	6 months after enrollment	Discontinuation of mineralocorticoid receptor antagonist
Switching from one mineralocorticoid receptor antagonist to another	6 months after enrollment	Changing the mineralocorticoid receptor antagonist used
Adverse effects	6 months after enrollment	The occurrence of Hyperkalemia, hypochloremic alkalosis, dehydration, or MRA adverse effects
Acute Kidney Injury	6 months after enrollment	The incidence of acute kidney injury

Secondary Outcome Measures

Name	Time	Method
All-cause hospitalization rate	6 months after enrollment	Hospitalization due to any cause including heart failure
All-cause mortality rate	6 months after enrollment	Death due to any cause

Trial Locations

Locations (1)

Faculty of Medicine, Alexandria University Hospitals; 🇪🇬 Alexandria, Egypt