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

• Sponsor: Samsung Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT01991119
• Collaborator: (none)
• Enrollment: 98
• Location: 1
• Arms: 2
• Duration (Months): 29
• Patients Per Site Per Month: 3.4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation	Drug: Propafenone; Drug: Dronedarone	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 98 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Efficacy of Propafenone Versus Dronedarone for the Maintenance of Sinus Rhythm in Patients With Atrial Fibrillation After DC Cardioversion
• Study Start Date: May 1, 2011
• Actual Primary Completion Date: Oct 1, 2013
• Actual Study Completion Date: Oct 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. recurrence of atrial fibrillation [6 month]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cardiac and Vascular Center	Seoul		Korea, Republic of	135-710

Sponsors and Collaborators

• Samsung Medical Center

Investigators

• Principal Investigator: Young Keun On, MD, PhD, Samsung Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Young Keun On, Principle investigator, Samsung Medical Center
• ClinicalTrials.gov Identifier: NCT01991119
• Other Study ID Numbers: 2011-03-085-001
• First Posted: Nov 25, 2013
• Last Update Posted: Nov 25, 2013
• Last Verified: Nov 1, 2013

• Keywords provided by Young Keun On, Principle investigator, Samsung Medical Center: Atrial fibrillation; Propafenone; Dronedarone
• Additional relevant MeSH terms: Atrial Fibrillation; Dronedarone; Propafenone

Study Results

No Results Posted as of Nov 25, 2013