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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000004600
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Tohoku University Hospital
Cardiovascular Surgery
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005492

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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