NCT06641284Completed
Gender-Based Differences in Heart Failure Hospitalizations Among Patients With Heart Failure Treated With Spironolactone
Gender-Based Differences in Heart Failure Hospitalizations Among Patients With Heart Failure With Reduced Ejection Fraction Treated With Spironolactone: A Prospective Cohort Study
Source: ClinicalTrials.gov · Last updated 24 Mar 2025
Brief summary (registry, in English)
Aldosterone antagonists or mineralocorticoid receptor antagonists (MRAs) are used as therapeutic agents for the management of HF with reduced ejection fraction (HFrEF). Gender-related differences have been described in the regulation of the 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 the RAAS, even though studies have suggested that androgens may increase the RAAS pathway. There are conflicting results because many clinical trials were not specifically designed to investigate gender differences.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 509 (actual)
- First submitted
- 11 Oct 2024
- Start date
- Oct 2023
- Primary completion date
- Oct 2024
- Lead sponsor
- Ahmad Abdullah Salawi
- Diseases
- Heart failure
- NCT number
- NCT06641284
What you commit to
- Study type: Observational
- Participants enrolled: 509
- From Oct 2023 to the primary completion date, Oct 2024
- 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 transplantation
- Concomitant administration of potent CYP3A inhibitors
- Patients who used MRA in the last 2 weeks before enrollment.
Other illness
- Disorders of the adrenal glands (such as Addison disease).
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 breastfeeding
Who the study is looking for
- All adult (≥ 18 years) ambulatory patients of both sexes with a diagnosis of HFrEF (LVEF≤ 40%) and NYHA class II-IV under optimized medical therapy who are presented to the outpatient clinic and started spironolactone at the time of enrollment.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| King Fahd Central Hospital Coordinator of this site? Confirm its status | Al ‘Usaylah | Saudi Arabia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.