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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000427
Receipt No. R000000519
Scientific Title A Randomized Study of Angiotensin II Type 1 Receptor Blocker vs Dihydropidine Ca Antagonist for Treatment of Paroxysmal Atrial Fibrillation in Patients with Hypertension
Date of disclosure of the study information 2006/07/10
Last modified on 2010/04/06

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Basic information
Public title A Randomized Study of Angiotensin II Type 1 Receptor Blocker vs Dihydropidine Ca Antagonist for Treatment of Paroxysmal Atrial Fibrillation in Patients with Hypertension
Acronym J-RHYTHM II Study
Scientific Title A Randomized Study of Angiotensin II Type 1 Receptor Blocker vs Dihydropidine Ca Antagonist for Treatment of Paroxysmal Atrial Fibrillation in Patients with Hypertension
Scientific Title:Acronym J-RHYTHM II Study
Region
Japan

Condition
Condition Atrial Fibrillation with Hypertension
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine whether candesartan, an ARB, has antiarrhythmic effects on paroxysmal AF beyond its BP lowering effects in comparison with amlodipine, a dyhydropyridine CCB, in patients with paroxysmal atrial fibrillation and hypertension
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the difference in the number of days with symptomatic and asymptomatic AF recorded on transtelephonic monitoring during the last 1 month of a 1-year follow-up between candesartan and amlodipine groups
Key secondary outcomes (1) cardiovascular events, which include cardiac death, myocardial infarction, cerebral infarction, and congestive heart failure or major bleeding requiring hospitalization (2) the development of paroxysmal AF into persistent AF lasting 7days or more, and/or requiring electrical conversion (3) quality of life assessed by the AFQLQ (Atrial Fibrillation specific Quality of Life Questionnaire) (4) left atrial dimension in ultrasound echocardiography (5) the number of days with symptomatic TTM-recorded AF (6) the time-course of the number of days with TTM-recorded AF per month after entering the study

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 ARB Group: candesartan will be prescribed with an initial dose of 8 mg/day (maximal dose 12 mg/day)
Interventions/Control_2 CCB Group: amlodipine will be prescribed with an initial dose of 2.5 mg/day (maximal dose 5 mg/day)
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients entering this study need to meet both of the following criteria: (1) a history of paroxysmal AF within 6 months, and (2) hypertension, defined as a systolic blood pressure (BP) > 140 mmHg and/or a diastolic BP > 90 mmHg. Paroxysmal AF should be a spontaneously terminating episode demonstrated on ECG.
Key exclusion criteria The exclusion criteria are (1) normal BP (systolic/diastolic BP < 140/90 mmHg), (2) a history of vasospastic angina pectoris, (3) persistent AF with a duration of 1 week or longer, and/or permanent AF, (4) AF that has occurred within 1 month of the onset of myocardial infarction, (5) transient AF associated with cardiac surgery, (6) contraindication for anticoagulation therapy, (7) pregnancy or the possibility of pregnancy, and breast feeding, (8) patient age of 18 or less, and (9) a judgment by the attending physician that patient participation would be inappropriate
Target sample size 400

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 Takeshi Yamashita
Organization The Cardiovascular Institute
Division name J-RHYTHM II Clinical Trial Center
Zip code
Address 7-3-10, Roppongi, Minato-ku, Tokyo
TEL
Homepage URL
Email j-rhythm2@cvi.or.jp

Sponsor
Institute The J-RHYTHM II 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
2006 Year 07 Month 10 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
2006 Year 07 Month 09 Day
Date of IRB
Anticipated trial start date
2006 Year 10 Month 01 Day
Last follow-up date
2009 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2006 Year 06 Month 05 Day
Last modified on
2010 Year 04 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000519

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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