UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study on the Effect of Irbesartan on Atrial Fibrillation Recurrence in Kumamoto: AF Suppression Trial
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Hisao Ogawa
Organization	Faculty Of Life Science Kumamoto University
Division name	Cardiovascular Medicine
Address	1-1-1 Honjou Kumamoto City Kumamoto
TEL	096-373-5175
Email	ogawah@kumamoto-u.ac.jp

Public contact
Name of contact person	Hiroshige Yamabe
Organization	Kumamoto University School of Medicine University Hospital, Department of Cardiac Arrhythmias
Division name	Department Of Cardiac Arrhythmias
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 12 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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