Investigation of the Optimal Treatment Strategy for Atrial Fibrillation in Japan -The J-RHYTHM (Japanese Rhythm Management Trial for Atrial Fibrillation) Study-

UMIN ID: C000000106

Registered date:08/09/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Atrial Fibrillation
• Date of first enrollment: 2003/01/01
• Target sample size: 2600
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Rhythm Control Group:Antiarrhythmic drugs will be selected on the basis of
Heart Rate Control Group:The target heart rate is 60-80 beats/min at rest.Patients will receive digitalis,Ca antagonists(excluding bepridil),or b-blockers as required, selected on the basis of the patient's clinical.

Outcome(s)

• Primary Outcome: Primary end-point(composite end-point):total mortality,symptomatic cerebral infarction,systemic embolism,major bleeding,hospitalization for heart failure requiring intravenous administration of diuretics,or physical/psychological disablement requiring discontinuation of the assigned therapeutic strategy.
• Secondary Outcome: Secondary end-point:patient QOL scores and the efficacy and safety of drugs required in the AF treatment.

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: Exclusion criteria are as follows. 1)Persistent AF lasting 1 year or longer,and permanent AF. 2)Initial episode of paroxysmal AF. 3)AF that has occurred within 1 month of the onset of myocardial infarction. 4)Transient AF associated with cardiac surgery. 5)Requirement of continuous treatment with b-blockers and Ca antagonists, excluding dihydropyridines, that affect the heart rate. 6)AF with a history of 2 or more electrical cardioversions. 7)Contraindication for anticoagulation therapy. 8)Pregnancy or possibility of pregnancy, and breast feeding. 9)Judgment by attending physician that patient participation would be inappropriate.

Related Information

• Primary Sponsor: The J-RHYTHM Investigators
• Source(s) of Monetary Support: Japan Heart Foundation