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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005205
Receipt No. 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

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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
Email 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
Email yyamabe@kumamoto-u.ac.jp

Sponsor
Institute Kumamoto University School of Medicine University Hospital, Department of Cardiac Arrhythmias
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006097

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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