Clinical trial NCT06233695: Gender-based Differences in the Outcome of Treatment With Aldosterone Antagonists in Patients With Heart Failure
Official title: The Gender-Based Differences in the Outcome of Treatment by Aldosterone Antagonists in Patients With Heart Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2024-01-31
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: New York Heart Association (NYHA) class II-IV heart failure with reduced ejection fraction HFrEF patients (LVEF≤ 40%).

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.


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.

Primary outcomes:
measure: Heart failure hospitalization
timeFrame: 6 months after enrollment
measure: Acute myocardial infarction
timeFrame: 6 months after enrollment
measure: Percentage of patients who discontinued mineralocorticoid receptor antagonist
timeFrame: 6 months after enrollment
measure: Switching from one mineralocorticoid receptor antagonist to another
timeFrame: 6 months after enrollment
measure: Acute Kidney Injury
timeFrame: 6 months after enrollment
measure: Adverse effects
timeFrame: 6 months after enrollment
Secondary outcomes:
measure: All-cause hospitalization rate
timeFrame: 6 months after enrollment
measure: All-cause mortality rate
timeFrame: 6 months after enrollment
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Medicine, Alexandria University Hospitals
Study officials:
affiliation: Cardiology Department, Faculty of Medicine, Alexandria University
name: Salah Abdelkader, MSc
role: PRINCIPAL_INVESTIGATOR
References: