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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005377
Receipt No. R000006274
Scientific Title Effectiveness of angiotensin II receptor blocker for postoperative atrial fibrillation in patients with open heart surgery
Date of disclosure of the study information 2011/04/04
Last modified on 2015/12/25

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Basic information
Public title Effectiveness of angiotensin II receptor blocker for postoperative atrial fibrillation in patients with open heart surgery
Acronym Effectiveness of angiotensin II receptor blocker for postoperative atrialfibillation
Scientific Title Effectiveness of angiotensin II receptor blocker for postoperative atrial fibrillation in patients with open heart surgery
Scientific Title:Acronym Effectiveness of angiotensin II receptor blocker for postoperative atrialfibillation
Region
Japan

Condition
Condition patients of open heart surgery with hypertention
Classification by specialty
Surgery in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate whether the observed protective effect against postoperative atrial fibrillation by administration of ARB (Irvesartan) before cardiac surgery
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Existence of atrial fibrillation and side effects
Key secondary outcomes length of intensive care unit, length of postoperative stay, incidence of atrial fibrillation

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 irvesartan (+)
Interventions/Control_2 irvesartan (-)
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
85 years-old >
Gender Male and Female
Key inclusion criteria Informed consent was obtained from patients
Key exclusion criteria 1) a history of hypersensitivity to any component of irbesartan
2) pregnant or potentially pregnant women
3) severe hypertension
4) persistent atrial fibrillation
5) treated with antiarrhythmic drug
6) atrioventricular block
7) parenteral antihypertensive drugs indicated in hypertensive emergency
8) undergoing hemodialysis
9) myocardial infarction within 6 months before study entry, or stroke attack
10) severe heart failure, or arrhythmia
11) severe renal dysfunction
12) severe liver dysfunction
13) uncontrolled diabetes
14) participated in other clinical trials, or treated with the drug test within 3 months
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kimikazu Hamano
Organization Department of Surgery and Clinical Science, Yamaguchi University Graduate School of Medicine
Division name Division of Cardiac Surgery
Zip code
Address 1-1-1 Minami-Kogushi, Ube, Yamaguchi 755-8505, Japan
TEL 0836-22-2261
Email dokky1@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ryo Suzuki
Organization Department of Surgery and Clinical Science, Yamaguchi University Graduate School of Medicine
Division name Division of Cardiac Surgery
Zip code
Address 1-1-1 Minami-Kogushi, Ube, Yamaguchi 755-8505, Japan
TEL 0836-22-2261
Homepage URL
Email dokky1@yahoo.co.jp

Sponsor
Institute Department of Surgery and Clinical Science, Yamaguchi University Graduate School of Medicine
Institute
Department

Funding Source
Organization Department of Surgery and Clinical Science, Yamaguchi University Graduate School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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 山口大学附属病院(山口県)

Other administrative information
Date of disclosure of the study information
2011 Year 04 Month 04 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 06 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 08 Month 01 Day
Last follow-up date
2012 Year 06 Month 01 Day
Date of closure to data entry
2012 Year 06 Month 01 Day
Date trial data considered complete
2015 Year 12 Month 24 Day
Date analysis concluded
2015 Year 12 Month 24 Day

Other
Other related information

Management information
Registered date
2011 Year 04 Month 04 Day
Last modified on
2015 Year 12 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006274

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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