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

NCT06233695 | Completed DMC FDA Drug

• 1 other identifier: GBDAL-HF Trial
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

Heart Failure; Heart Failure with Reduced Ejection Fraction; Gender; Eplerenone; Spironolactone; Hospitalization

Outcome Measures

Primary Outcomes (6)

• Heart failure hospitalization

  The incidence of Hospitalization due to heart failure

  6 months after enrollment

• Acute myocardial infarction

  The incidence of acute myocardial infarction

  6 months after enrollment

• Percentage of patients who discontinued mineralocorticoid receptor antagonist

  Discontinuation of mineralocorticoid receptor antagonist

  6 months after enrollment

• Switching from one mineralocorticoid receptor antagonist to another

  Changing the mineralocorticoid receptor antagonist used

  6 months after enrollment

• Acute Kidney Injury

  The incidence of acute kidney injury

  6 months after enrollment

• Adverse effects

  The occurrence of Hyperkalemia, hypochloremic alkalosis, dehydration, or MRA adverse effects

  6 months after enrollment

Secondary Outcomes (2)

• All-cause hospitalization rate

  6 months after enrollment

• All-cause mortality rate

  6 months after enrollment

Study Arms (2)

The Female Group

Patients with an apparent gender of female.

Drug: Potassium sparing diuretic

The Male Group

Patients with an apparent gender of male.

Drug: Potassium sparing diuretic

Interventions

Potassium sparing diuretic DRUG

Starting Spironolactone or Eplerenone at the time of enrollment.

The Female Group; The Male Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

New York Heart Association (NYHA) class II-IV heart failure with reduced ejection fraction HFrEF patients (LVEF≤ 40%).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Faculty of Medicine, Alexandria University Hospitals

Alexandria, Egypt

Location

MeSH Terms

Conditions

Heart Failure; Coitus

Interventions

Sodium Channel Blockers

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Sexual Behavior; Behavior

Intervention Hierarchy (Ancestors)

Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Cardiovascular Agents; Therapeutic Uses

Study Officials

• Salah Abdelkader, MSc

  Cardiology Department, Faculty of Medicine, Alexandria University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2024
• First Posted: January 31, 2024
• Study Start: October 15, 2022
• Primary Completion: July 15, 2023
• Study Completion: December 1, 2023
• Last Updated: February 26, 2024

Record last verified: 2024-01

Locations

EG (1)