Gender-based Differences in the Outcome of Treatment With Aldosterone Antagonists in Patients Wit… (NCT06233695) | Clinical Trial Compass
CompletedNot Applicable
Gender-based Differences in the Outcome of Treatment With Aldosterone Antagonists in Patients With Heart Failure
Egypt100 participantsStarted 2022-10-15
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Heart failure hospitalization
Timeframe: 6 months after enrollment
2
Acute myocardial infarction
Timeframe: 6 months after enrollment
3
Percentage of patients who discontinued mineralocorticoid receptor antagonist
Timeframe: 6 months after enrollment
4
Switching from one mineralocorticoid receptor antagonist to another