The Gender-Based Differences in the Outcome of Treatment by Aldosterone Antagonists in Patients With Heart Failure
Overview
- Phase
- Not Applicable
- Intervention
- Potassium sparing diuretic
- Conditions
- Heart Failure
- Sponsor
- Alexandria University
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Switching from one mineralocorticoid receptor antagonist to another
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
The Female Group
Patients with an apparent gender of female.
Intervention: Potassium sparing diuretic
The Male Group
Patients with an apparent gender of male.
Intervention: Potassium sparing diuretic
Outcomes
Primary Outcomes
Switching from one mineralocorticoid receptor antagonist to another
Time Frame: 6 months after enrollment
Changing the mineralocorticoid receptor antagonist used
Heart failure hospitalization
Time Frame: 6 months after enrollment
The incidence of Hospitalization due to heart failure
Acute myocardial infarction
Time Frame: 6 months after enrollment
The incidence of acute myocardial infarction
Percentage of patients who discontinued mineralocorticoid receptor antagonist
Time Frame: 6 months after enrollment
Discontinuation of mineralocorticoid receptor antagonist
Adverse effects
Time Frame: 6 months after enrollment
The occurrence of Hyperkalemia, hypochloremic alkalosis, dehydration, or MRA adverse effects
Acute Kidney Injury
Time Frame: 6 months after enrollment
The incidence of acute kidney injury
Secondary Outcomes
- All-cause hospitalization rate(6 months after enrollment)
- All-cause mortality rate(6 months after enrollment)