UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004600 |
|---|---|
| Receipt number | R000005492 |
| Scientific Title | Evaluation of the preventive effect of bisoprolol fumarate on postoperative hypertension and atrial fibrillation in in eldery patient on acute and chronic phase. |
| Date of disclosure of the study information | 2010/12/01 |
| Last modified on | 2010/11/22 15:41:26 |
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Basic information
Public title
Evaluation of the preventive effect of bisoprolol fumarate on postoperative hypertension and atrial fibrillation in in eldery patient on acute and chronic phase.
Acronym
EBAF study
Scientific Title
Evaluation of the preventive effect of bisoprolol fumarate on postoperative hypertension and atrial fibrillation in in eldery patient on acute and chronic phase.
Scientific Title:Acronym
EBAF study
Region
| Japan |
Condition
Condition
Postoperative atrial fibrillation
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the preventive effect of bisoprolol fumarate on postoperative hypertension and atrial fibrillation in eldery patient on acute and chronic phase
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Occurrence of postoperative atrial fibrillation
Key secondary outcomes
the activated level of sympathetic nerve(Holter ECG)
cardiovascular event
level of inflammatory biomarker
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administration bisoprolol fumarate (initial dose is 2.5mg)
Interventions/Control_2
Conventional care without administration of bisoprolol fumarate
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
| 70 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
all elective cases in our department
(cardiac and aortic surgery)
Key exclusion criteria
patients on beta-blocker preoperatively
patients with likelihood for ostoperative beta-blocker therapy
co-morbid bronchial asthma (FEV1.0 less than 1000ml)
co-morbid diabetes mellitus (HbA1c more than 8 percent)
persistent atrial fibrillation before entering ICU
the case already implanted permanent pacemaker
allergic to bisoprolol fumarate
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshikatsu Saiki |
Organization
Tohoku University Hospital
Division name
Cardiovascular Surgery
Zip code
Address
Aobaku seiryocho 1-1,
TEL
022-717-7222
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshikatsu Saiki |
Organization
Tohoku University Hospotal
Division name
Cardiovascular Surgery
Zip code
Address
Aobaku seiryocho 1-1,
TEL
022-717-7222
Homepage URL
Sponsor or person
Institute
Tohoku University Hospital
Cardiovascular Surgery
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
東北大学病院(宮城県) /Tohoku University Hospital(Miyagi pref.)
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 12 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2010 | Year | 11 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 11 | Month | 22 | Day |
Last modified on
| 2010 | Year | 11 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005492
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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