Unique ID issued by UMIN | C000000106 |
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Receipt number | R000000151 |
Scientific Title | Investigation of the Optimal Treatment Strategy for Atrial Fibrillation in Japan -The J-RHYTHM (Japanese Rhythm Management Trial for Atrial Fibrillation) Study- |
Date of disclosure of the study information | 2005/09/08 |
Last modified on | 2006/09/19 16:28:28 |
Investigation of the Optimal Treatment Strategy for Atrial Fibrillation in Japan -The J-RHYTHM (Japanese Rhythm Management Trial for Atrial Fibrillation) Study-
J-RHYTHM Study
Investigation of the Optimal Treatment Strategy for Atrial Fibrillation in Japan -The J-RHYTHM (Japanese Rhythm Management Trial for Atrial Fibrillation) Study-
J-RHYTHM Study
Japan |
Atrial Fibrillation
Cardiology |
Others
NO
The J-RHYTHM study will investigate and compare the usefulness of rhythm control therapy and rate control therapy in patients with paroxysmal and persistent AF with a composite primary end-point of 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.The composite secondary end-point of this study is patient QOL scores and the efficacy and safety of drugs required in the AF treatment.
Safety,Efficacy
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 end-point:patient QOL scores and the efficacy and safety of drugs required in the AF treatment.
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
2
Treatment
Medicine |
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.
Not applicable |
Not applicable |
Male and Female
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 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.
2600
1st name | |
Middle name | |
Last name | Satoshi Ogawa |
Keio University School of Medicine
Department of internal Medicine
35 Shinanomachi,Shinjuku-ku,Tokyo
1st name | |
Middle name | |
Last name |
The Cardiovascular Institute
J-RHYTHM Clinical Trail Center
j-rhythm@cvi.or.jp
The J-RHYTHM Investigators
Japan Heart Foundation
Non profit foundation
NO
2005 | Year | 09 | Month | 08 | Day |
Unpublished
Completed
2002 | Year | 11 | Month | 02 | Day |
2003 | Year | 01 | Month | 01 | Day |
2006 | Year | 03 | Month | 01 | Day |
2006 | Year | 03 | Month | 01 | Day |
2006 | Year | 08 | Month | 01 | Day |
2006 | Year | 12 | Month | 01 | Day |
2005 | Year | 09 | Month | 01 | Day |
2006 | Year | 09 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000151
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