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

Alexandria University100 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.