UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000106 |
|---|---|
| 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 |
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Basic information
Public title
Investigation of the Optimal Treatment Strategy for Atrial Fibrillation in Japan -The J-RHYTHM (Japanese Rhythm Management Trial for Atrial Fibrillation) Study-
Acronym
J-RHYTHM Study
Scientific Title
Investigation of the Optimal Treatment Strategy for Atrial Fibrillation in Japan -The J-RHYTHM (Japanese Rhythm Management Trial for Atrial Fibrillation) Study-
Scientific Title:Acronym
J-RHYTHM Study
Region
| Japan |
Condition
Condition
Atrial Fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
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.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
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.
Key secondary outcomes
Secondary end-point:patient QOL scores and the efficacy and safety of drugs required in the AF treatment.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Rhythm Control Group:Antiarrhythmic drugs will be selected on the basis of
Interventions/Control_2
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.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key 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.
Key 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.
Target sample size
2600
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Ogawa |
Organization
Keio University School of Medicine
Division name
Department of internal Medicine
Zip code
Address
35 Shinanomachi,Shinjuku-ku,Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
The Cardiovascular Institute
Division name
J-RHYTHM Clinical Trail Center
Zip code
Address
TEL
Homepage URL
j-rhythm@cvi.or.jp
Sponsor or person
Institute
The J-RHYTHM Investigators
Institute
Department
Personal name
Funding Source
Organization
Japan Heart Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2005 | Year | 09 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2002 | Year | 11 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2003 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2006 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2006 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2006 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2006 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2005 | Year | 09 | Month | 01 | Day |
Last modified on
| 2006 | Year | 09 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000151
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