UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000427 |
|---|---|
| Receipt number | 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 15:39:39 |
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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
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
j-rhythm2@cvi.or.jp
Sponsor or person
Institute
The J-RHYTHM II 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
| 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000519
