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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06233695
Other study ID # GBDAL-HF Trial
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 15, 2022
Est. completion date December 1, 2023

Study information

Verified date January 2024
Source Alexandria University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date December 1, 2023
Est. primary completion date July 15, 2023
Accepts healthy volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Potassium sparing diuretic
Starting Spironolactone or Eplerenone at the time of enrollment.

Locations

Country Name City State
Egypt Faculty of Medicine, Alexandria University Hospitals Alexandria

Sponsors (1)

Lead Sponsor Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Heart failure hospitalization The incidence of Hospitalization due to heart failure 6 months after enrollment
Primary Acute myocardial infarction The incidence of acute myocardial infarction 6 months after enrollment
Primary Percentage of patients who discontinued mineralocorticoid receptor antagonist Discontinuation of mineralocorticoid receptor antagonist 6 months after enrollment
Primary Switching from one mineralocorticoid receptor antagonist to another Changing the mineralocorticoid receptor antagonist used 6 months after enrollment
Primary Acute Kidney Injury The incidence of acute kidney injury 6 months after enrollment
Primary Adverse effects The occurrence of Hyperkalemia, hypochloremic alkalosis, dehydration, or MRA adverse effects 6 months after enrollment
Secondary All-cause hospitalization rate Hospitalization due to any cause including heart failure 6 months after enrollment
Secondary All-cause mortality rate Death due to any cause 6 months after enrollment
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