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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000106
Receipt No. 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

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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
Email

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
Email j-rhythm@cvi.or.jp

Sponsor
Institute The J-RHYTHM Investigators
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000151

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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