Atrial Fibrillation
Conditions
Interventions
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(exc
Sponsors
The J-RHYTHM Investigators
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria:paroxysmal AF and persistent AF. Paroxysmal AF is defined as AF in which spontaneous conversion to sinus rhythm is expected within less than 48 hours of onset. Persistent AF is defined as AF that persists for more than 48 hours and less than 1 year after onset.
Exclusion criteria
Exclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary end-point:patient QOL scores and the efficacy and safety of drugs required in the AF treatment. | — |
Countries
Japan
Outcome results
None listed