Efficacy of Propafenone Versus Dronedarone for the Maintenance of Sinus Rhythm in Patients With Atrial Fibrillation

November 17, 2013 updated by: Young Keun On, Samsung Medical Center

Efficacy of Propafenone Versus Dronedarone for the Maintenance of Sinus Rhythm in Patients With Atrial Fibrillation After DC Cardioversion

the purpose of this study is to compare the ability of propafenone and dronedarone to maintain sinus rhythm after DC cardioversion

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Atrial fibrillation is the most common arrhythmia requiring continuous therapy. Conversion to and maintenance of sinus rhythm is important. Propafenone and dronedarone has been used as treatment for maintenance of sinus rhythm after DC cardioversion. But there are no direct comparison study.

The purpose of this study is to compare the ability of propafenone and dronedarone to maintain sinus rhythm after DC cardioversion.

Study Type

Interventional

Enrollment (Actual)

98

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • a patient with persistent atrial fibrillation who received successful DC cardioversion

Exclusion Criteria:

  • prior amiodarone use
  • NYHA class III or IV heart failure
  • Left ventricular ejection fraction < 35%
  • second or third AV block
  • sick sinus syndrome
  • heart rate < 50 beat per minute
  • myocardiac infarction within 3 months
  • pregnant women
  • severe hepatic dysfunction
  • QT prolongation > 500ms or PR interval > 180ms
  • history of hypersensitivity for drug

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Propafenone
Propafenone group
Drug: Propafenone
Active Comparator: Dronedarone
Dronedarone group
Drug: Dronedarone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
recurrence of atrial fibrillation
Time Frame: 6 month
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

November 7, 2013

First Submitted That Met QC Criteria

November 17, 2013

First Posted (Estimate)

November 25, 2013

Study Record Updates

Last Update Posted (Estimate)

November 25, 2013

Last Update Submitted That Met QC Criteria

November 17, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-03-085-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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