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Effect of Dronedarone on Atrial Fibrosis Progression and Atrial Fibrillation Recurrence

NCT04704050 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2025-10-30

Study results available
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Summary

Patients who have undergone cardiac ablation will be randomized and blinded to one of two groups; one group will receive dronedarone while the other group will receive a placebo. The incidence of atrial fibrillation recurrence, as well as atrial fibrosis progression, will be analyzed between the two trial groups.

Conditions

Interventions

DRUG

dronedarone 400 mg Oral Tablet

Dronedarone is an anti-arrhythmic drug with properties belonging to Vaughan-Williams class I-IV. Participants will receive dronedarone 400 mg tablet, to be taken orally and twice daily for 52 weeks.

DRUG

Placebo

Participants will receive a placebo tablet matching the physical appearance of dronedarone, to be taken orally and twice daily for 52 weeks.

Sponsors & Collaborators

  • University of Washington

    collaborator OTHER

  • Marrek, INC

    collaborator UNKNOWN

  • Sanofi

    collaborator INDUSTRY

  • Preventice

    collaborator INDUSTRY

  • Mckesson

    collaborator UNKNOWN

  • Tulane University School of Medicine

    lead OTHER

Principal Investigators

  • Nassir F Marrouche, MD · Tulane University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-15
Primary Completion
2022-12-20
Completion
2022-12-20
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04704050 on ClinicalTrials.gov