NCT06168994

Brief Summary

The aim of this study is to study synergistic effect of eplerenone as Selective aldosterone receptor antagonist with amiodarone compared with amiodarone only in reducing recurrence of atrial fibrillation in patient with structural heart disease

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
12mo left

Started Feb 2024

Typical duration for phase_4

Status
not yet 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 Progress69%
Feb 2024May 2027

First Submitted

Initial submission to the registry

December 5, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 13, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2024

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2026

Expected
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2027

Last Updated

December 13, 2023

Status Verified

December 1, 2023

Enrollment Period

2.7 years

First QC Date

December 5, 2023

Last Update Submit

December 5, 2023

Conditions

Paroxysmal Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • Role of eplerenone in reducing recurrence of atrial fibrillation in patient with structural heart disease

    decrease recurrence of paroxysmal AF in patient of structural heart disease

    Baseline

Study Arms (2)

Amiodarone as comparison

ACTIVE COMPARATOR

50 patients \>\>Amiodarone +other treatmen

Drug: Eplerenone

Eplerenone plus amiodarone

EXPERIMENTAL

50 patients \>\>Amiodarone +other treatmen

Drug: Eplerenone

Interventions

EplerenoneDRUG

Amiodarone vs eplerenone in AF

Amiodarone as comparisonEplerenone plus amiodarone

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \- paroxysmal AF who reverted to sinus rhythm either medically or electrically without appropriate secondary cause of primary AF
  • AF attack should be documented with ECG

You may not qualify if:

  • patients are currently on eplerenone or spironolactone 2-hyperkalemia 3-impaired renal function(if CrCl \<50ml/min or serum creatinine\>2 mg/dl) 4-patient on beta blocker and calcium channel blocker (non- dihydropyridine) 5-prosthetic valve 6-severe mitral stenosis 7-thyroid dysfunction 8-WPW 9-severe liver disease 10-persistent or permanent AF 11-pregnancy or breast feeding 12-LV EF\<50% 13-known hypersensitivity or drug reaction to amiodarone 14-acute coronary syndrome 15-refusal of consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Eplerenone

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

LactonesOrganic ChemicalsPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Central Study Contacts

Walid Abdellah

CONTACT

01158931616walidshehata573@gmail.com

Hatem Helmy

CONTACT

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

December 5, 2023

First Posted

December 13, 2023

Study Start

February 1, 2024

Primary Completion (Estimated)

September 29, 2026

Study Completion (Estimated)

May 20, 2027

Last Updated

December 13, 2023

Record last verified: 2023-12