NIPH Clinical Trials Search

UMIN ID: C000000106

Registered date:08/09/2005

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

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedAtrial Fibrillation
Date of first enrollment2003/01/01
Target sample size2600
Countries of recruitmentJapan
Study typeInterventional
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.


Primary OutcomePrimary 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 OutcomeSecondary end-point:patient QOL scores and the efficacy and safety of drugs required in the AF treatment.

Key inclusion & exclusion criteria

Age minimumNot applicable
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteriaExclusion 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


public contact
Address Japan
Affiliation The Cardiovascular Institute J-RHYTHM Clinical Trail Center
scientific contact
Name Satoshi Ogawa
Address 35 Shinanomachi,Shinjuku-ku,Tokyo Japan
Affiliation Keio University School of Medicine Department of internal Medicine