NCT06556732

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P75+ for phase_1 atrial-fibrillation

Timeline
Completed

Started Aug 2024

Shorter than P25 for phase_1 atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 10, 2024

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 12, 2024

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 13, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 16, 2024

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
Last Updated

August 16, 2024

Status Verified

August 1, 2024

Enrollment Period

3 days

First QC Date

August 12, 2024

Last Update Submit

August 14, 2024

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • AF recurrence

    6 months

Study Arms (2)

Study arm

EXPERIMENTAL

Were given Eplereone 25 mg daily

Drug: Eplereone

Control arm

PLACEBO COMPARATOR

Were given nothing

Drug: Eplereone

Interventions

EplereoneDRUG

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.

Also known as: Amiodarone
Control armStudy arm

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University Heart Hospital

Asyut, 71526, Egypt

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Amiodarone

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 12, 2024

First Posted

August 16, 2024

Study Start

August 10, 2024

Primary Completion

August 13, 2024

Study Completion

August 31, 2024

Last Updated

August 16, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)