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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | Atrial Fibrillation | |
Classification by specialty |
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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 |
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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 | ||
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Interventions/Control_5 | ||
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Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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. |
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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. |
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Target sample size | 2600 |
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Name of lead principal investigator |
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Organization | Keio University School of Medicine | ||||||
Division name | Department of internal Medicine | ||||||
Zip code | |||||||
Address | 35 Shinanomachi,Shinjuku-ku,Tokyo | ||||||
TEL | |||||||
Public contact | |||||||
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Organization | The Cardiovascular Institute | ||||||
Division name | J-RHYTHM Clinical Trail Center | ||||||
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Homepage URL | |||||||
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 |
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Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
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Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Baseline Characteristics | |
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Progress | |||||||
Recruitment status | Completed | ||||||
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Other | |
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Management information | |||||||
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Last modified on |
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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 | |
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Research case data | |
Registered date | File name |