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

A

Assiut University

Status and phase

Enrolling
Phase 1

Conditions

Atrial Fibrillation

Treatments

Drug: Eplereone

Study type

Interventional

Funder types

Other

Identifiers

NCT06556732
Eplerenone in AF 2020

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

20 to 70 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

100 participants in 2 patient groups, including a placebo group

Study arm
Experimental group
Description:
Were given Eplereone 25 mg daily
Treatment:
Drug: Eplereone
Control arm
Placebo Comparator group
Description:
Were given nothing
Treatment:
Drug: Eplereone

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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