Heart Failure, Heart Failure With Reduced Ejection Fraction, Heart Failure NYHA Class II, Heart Failure NYHA Class III, Heart Failure NYHA Class IV
Conditions
Keywords
Heart Failure, Heart Failure with Reduced Ejection Fraction, Gender, Eplerenone, Spironolactone, Hospitalization
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.
Interventions
Starting Spironolactone or Eplerenone at the time of enrollment.
Sponsors
Alexandria University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse effects | 6 months after enrollment | The occurrence of Hyperkalemia, hypochloremic alkalosis, dehydration, or MRA adverse effects |
| Switching from one mineralocorticoid receptor antagonist to another | 6 months after enrollment | Changing the mineralocorticoid receptor antagonist used |
| Acute Kidney Injury | 6 months after enrollment | The incidence of acute kidney injury |
| Heart failure hospitalization | 6 months after enrollment | The incidence of Hospitalization due to heart failure |
| Acute myocardial infarction | 6 months after enrollment | The incidence of acute myocardial infarction |
| Percentage of patients who discontinued mineralocorticoid receptor antagonist | 6 months after enrollment | Discontinuation of mineralocorticoid receptor antagonist |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality rate | 6 months after enrollment | Death due to any cause |
| All-cause hospitalization rate | 6 months after enrollment | Hospitalization due to any cause including heart failure |
Countries
Egypt
Outcome results
None listed