UMIN-CTR Clinical Trial

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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