Heart Failure Clinical Trial
— GBDAL-HFOfficial title:
The Gender-Based Differences in the Outcome of Treatment by Aldosterone Antagonists in Patients With Heart Failure
Verified date | January 2024 |
Source | Alexandria University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Egypt | Faculty of Medicine, Alexandria University Hospitals | Alexandria |
Lead Sponsor | Collaborator |
---|---|
Alexandria University |
Egypt,
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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