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Gender-based Differences in the Outcome of Treatment With Aldosterone Antagonists in Patients With Heart Failure

NCT06233695 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2024-02-26

No results posted yet for this study

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

DRUG

Potassium sparing diuretic

Starting Spironolactone or Eplerenone at the time of enrollment.

Sponsors & Collaborators

  • Alexandria University

    lead OTHER

Principal Investigators

  • Salah Abdelkader, MSc · Cardiology Department, Faculty of Medicine, Alexandria University

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-15
Primary Completion
2023-07-15
Completion
2023-12-01
FDA Drug
Yes

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06233695 on ClinicalTrials.gov