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Completed

NCT Number: NCT06233695

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

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.

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Key information

Conditions

Heart Failure Behavior Cardiovascular Diseases Coitus Heart Diseases Heart Failure NYHA Class II Heart Failure NYHA Class III Heart Failure NYHA Class IV Heart Failure With Reduced Ejection Fraction Sexual Behavior

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of Medicine, Alexandria University Hospitals

Alexandria, Egypt

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Potassium sparing diuretic

Drug

Starting Spironolactone or Eplerenone at the time of enrollment.

Primary outcomes

  1. Heart failure hospitalization

    Time frame: 6 months after enrollment

    The incidence of Hospitalization due to heart failure

  2. Acute myocardial infarction

    Time frame: 6 months after enrollment

    The incidence of acute myocardial infarction

  3. Percentage of patients who discontinued mineralocorticoid receptor antagonist

    Time frame: 6 months after enrollment

    Discontinuation of mineralocorticoid receptor antagonist

  4. Switching from one mineralocorticoid receptor antagonist to another

    Time frame: 6 months after enrollment

    Changing the mineralocorticoid receptor antagonist used

  5. Acute Kidney Injury

    Time frame: 6 months after enrollment

    The incidence of acute kidney injury

  6. Adverse effects

    Time frame: 6 months after enrollment

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

Secondary outcomes

  1. All-cause hospitalization rate

    Time frame: 6 months after enrollment

    Hospitalization due to any cause including heart failure

  2. All-cause mortality rate

    Time frame: 6 months after enrollment

    Death due to any cause

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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

Acronym: GBDAL-HF

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 31, 2024
Registry last updated
Feb 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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