Trials / Completed
CompletedNCT06233695
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
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 100 (actual)
- Sponsor
- Alexandria University · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- —
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.
Conditions
- Heart Failure
- Heart Failure With Reduced Ejection Fraction
- Heart Failure NYHA Class II
- Heart Failure NYHA Class III
- Heart Failure NYHA Class IV
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Potassium sparing diuretic | Starting Spironolactone or Eplerenone at the time of enrollment. |
Timeline
- Start date
- 2022-10-15
- Primary completion
- 2023-07-15
- Completion
- 2023-12-01
- First posted
- 2024-01-31
- Last updated
- 2024-02-26
Locations
1 site across 1 country: Egypt
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06233695. Inclusion in this directory is not an endorsement.