NCT06233695Completed
Gender-based Differences in the Outcome of Treatment With Aldosterone Antagonists in Patients With Heart Failure
The Gender-Based Differences in the Outcome of Treatment by Aldosterone Antagonists in Patients With Heart Failure
Source: ClinicalTrials.gov · Last updated 26 Feb 2024
Brief summary (registry, in English)
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 (registry)
- Completed
- Study type
- Observational
- Enrollment
- 100 (actual)
- First submitted
- 13 Jan 2024
- Start date
- 15 Oct 2022
- Primary completion date
- 15 Jul 2023
- Lead sponsor
- Alexandria University
- Diseases
- Heart failure
- NCT number
- NCT06233695
What you commit to
- Study type: Observational
- Participants enrolled: 100
- From 15 Oct 2022 to the primary completion date, 15 Jul 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Renal transplant.
- Concomitant administration of strong CYP3A inhibitors.
- Patients who used mineralocorticoid receptor antagonists in the last 2 weeks before enrollment.
Other illness
- Disorders of adrenal glands (Addison disease).
- Patients with a history of mineralocorticoid receptor antagonists allergy or intolerance.
Lab values
- 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).
- Concomitant administration of potassium supplements or potassium-sparing diuretics.
Other
- Pregnancy or breast-feeding.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Faculty of Medicine, Alexandria University Hospitals Coordinator of this site? Confirm its status | Alexandria | Egypt | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.