UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005205 |
|---|---|
| Receipt number | R000006097 |
| Scientific Title | Study on the Effect of Irbesartan on Atrial Fibrillation Recurrence in Kumamoto: AF Suppression Trial |
| Date of disclosure of the study information | 2011/03/14 |
| Last modified on | 2016/06/10 11:04:15 |
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Basic information
Public title
Study on the Effect of Irbesartan on Atrial Fibrillation Recurrence in Kumamoto: AF Suppression Trial
Acronym
SILK
Scientific Title
Study on the Effect of Irbesartan on Atrial Fibrillation Recurrence in Kumamoto: AF Suppression Trial
Scientific Title:Acronym
SILK
Region
| Japan |
Condition
Condition
Atrial Fibrillation and Hypertention
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This half year study will test the efficacy of irbesartan of maintaining sinus rhythm in hypertensives with paroxysmal or persistent atrial fibrillation scheduled for catheter ablation or electrical cardioversion, and the effects of irbesartan on biomarkers changes predicting recurrences of atrial fibrillation, assuming that preventing recurrences of atrial fibrillation affects predictive biomarkers changes.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rhythm Control
Key secondary outcomes
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
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Irbesartan
Interventions/Control_2
Amurojipin
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
| 20 | years-old | < |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Age-lower limit
20 and over
Key inclusion criteria
Outpatients in Kumamoto University hospital or related hospitals with paroxysmal or persistent atrial fibrillation scheduled for catheter ablation or electrical cardioversion, diagonosed with hypertension with or without treatment, who can give written informed consent
Key exclusion criteria
Key exclusion criteria
Patients were excluded from the study on the basis of the following criteria: contraindications to treatment with irbesartan or amlodipine; myocardial infarction during the previous 3 months; cardiac surgery during the previous 3 months; bradycardia<50 bpm while the patient was awake; unstable angina: NYHA heart failure class not less than III: QT interval not less than 480 ms in the absence of bundle-branch block; significant impairment of renal function: significant hepatic disease.
Target sample size
154
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hisao Ogawa |
Organization
Faculty Of Life Science Kumamoto University
Division name
Cardiovascular Medicine
Zip code
Address
1-1-1 Honjou Kumamoto City Kumamoto
TEL
096-373-5175
ogawah@kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshige Yamabe |
Organization
Kumamoto University School of Medicine University Hospital, Department of Cardiac Arrhythmias
Division name
Department Of Cardiac Arrhythmias
Zip code
Address
1-1-1 Honjou Kumamoto City Kumamoto
TEL
096-373-5175
Homepage URL
yyamabe@kumamoto-u.ac.jp
Sponsor or person
Institute
Kumamoto University School of Medicine University Hospital, Department of Cardiac Arrhythmias
Institute
Department
Personal name
Funding Source
Organization
SHIONOGI & CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
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
| 2011 | Year | 03 | Month | 14 | 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
| 2010 | Year | 12 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 03 | Month | 07 | Day |
Last modified on
| 2016 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006097
