UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005377 |
|---|---|
| Receipt number | 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 12:59:55 |
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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
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
dokky1@yahoo.co.jp
Sponsor or person
Institute
Department of Surgery and Clinical Science, Yamaguchi University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006274
