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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01991119
• Other study ID #: 2011-03-085-001
• Status: Completed
• Phase: N/A
• First received: November 7, 2013
• Last updated: November 17, 2013
• Start date: May 2011
• Est. completion date: October 2013

Study information

• Verified date: November 2013
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• Propafenone

• Dronedarone

Locations

Country	Name	City	State
Korea, Republic of	Cardiac and Vascular Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	recurrence of atrial fibrillation		6 month	No