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

Heart Failure Clinical Trial

— GBDAL-HF  

Official title:

The Gender-Based Differences in the Outcome of Treatment by Aldosterone Antagonists in Patients With Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06233695
• Other study ID #: GBDAL-HF Trial
• Status: Completed
• Start date: October 15, 2022
• Est. completion date: December 1, 2023

Study information

• Verified date: January 2024
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 1, 2023
• Est. primary completion date: July 15, 2023
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• Potassium sparing diuretic
Starting Spironolactone or Eplerenone at the time of enrollment.

Locations

Country	Name	City	State
Egypt	Faculty of Medicine, Alexandria University Hospitals	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart failure hospitalization	The incidence of Hospitalization due to heart failure	6 months after enrollment
Primary	Acute myocardial infarction	The incidence of acute myocardial infarction	6 months after enrollment
Primary	Percentage of patients who discontinued mineralocorticoid receptor antagonist	Discontinuation of mineralocorticoid receptor antagonist	6 months after enrollment
Primary	Switching from one mineralocorticoid receptor antagonist to another	Changing the mineralocorticoid receptor antagonist used	6 months after enrollment
Primary	Acute Kidney Injury	The incidence of acute kidney injury	6 months after enrollment
Primary	Adverse effects	The occurrence of Hyperkalemia, hypochloremic alkalosis, dehydration, or MRA adverse effects	6 months after enrollment
Secondary	All-cause hospitalization rate	Hospitalization due to any cause including heart failure	6 months after enrollment
Secondary	All-cause mortality rate	Death due to any cause	6 months after enrollment