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

NCT ID: NCT06556732

Last Updated: 2024-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-10

Study Completion Date

2024-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Atrial Fibrillation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Study arm

Were given Eplereone 25 mg daily

Group Type EXPERIMENTAL

Eplereone

Intervention Type DRUG

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.

Control arm

Were given nothing

Group Type PLACEBO_COMPARATOR

Eplereone

Intervention Type DRUG

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Amiodarone

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assiut University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ahmed Abdelgaleel

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Assiut University Heart Hospital

Asyut, , Egypt

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Ahmed Abdel-Galeel, MD

Role: primary

+201005024562

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Eplerenone in AF 2020

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.