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Recruiting NCT06556732

Role of Eplerenone in Reducing Recurrence of Atrial Fibrillation in Patients With Structural Heart Disease

Phase I Interventional Atrial Fibrillation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Eplereone.
Who it may be relevant to
Registry conditions: Atrial Fibrillation. Basic parameters: 20 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Potential Role of Eplerenone in Reducing Recurrence of Atrial Fibrillation in Patients With Structural Heart Disease

Overview

This is a prospective comparative study, conducted at Cardiology Department, Aswan University Hospital on AF patients with structural heart disease. Eplerenone 25 mg daily will be given and searching for AF recurrence among study population.

Detailed description

This is a prospective comparative study, conducted at Cardiology Department, Aswan University Hospital, on 100 patients with AF and structural heart disease. AF is confirmed by electrocardiography. The patients were divided into 2 groups:

Group A (study group): 50 patients received eplerenon 25 mg daily plus amiodarone and other medications not including non-dihydropyridine calcium channel blocker or digoxin.

Group B (control group): 50 patients received amiodarone and other medications not including non-dihydropyridine calcium channel blocker or digoxin.

Interventions

  • Drug Eplereone
    Group A (study group): 50 patients received eplerenon 25 mg daily plus amiodarone and other medications not including non-dihydropyridine calcium channel blocker or digoxin.

Primary outcome measures

  • AF recurrence [Time frame: 6 months]

Eligibility criteria

Inclusion criteria

  • Patients with non-valvular AF who underwent cardioversion to sinus rhythm either medical, electrical or even spontaneously

Exclusion criteria

  • Patients with rheumatic heart disease.
  • Thyroid dysfunction.
  • Wolf-Parkinson-White (WPW) syndrome.
  • Renal impairment.
  • Hyperkalemia.
  • Acute coronary syndrome.
  • Pregnancy.
  • Left ventricular (LV) dysfunction with ejection fraction (EF) less than 40%.
  • On current use of eplerenone.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

Egypt · 1 center
  • Assiut University Heart Hospital — Asyut

Identifiers

NCT: NCT06556732 · Eplerenone in AF 2020

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗