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

Samsung Medical Center

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Drug: Dronedarone; Drug: Propafenone

Study type: Interventional

Funder types: Other

Identifiers

NCT01991119

2011-03-085-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 98 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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98 participants in 2 patient groups

Propafenone

Active Comparator group

Description:

Propafenone group

Treatment:

Drug: Propafenone

Dronedarone

Active Comparator group

Description:

Dronedarone group

Treatment:

Drug: Dronedarone