UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002489
Receipt No. R000003052
Scientific Title Effect of beta blockers for prevention of atrial fibrillation after CABG: a randomised controlled trial
Date of disclosure of the study information 2009/09/15
Last modified on 2018/03/26

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Effect of beta blockers for prevention of atrial fibrillation after CABG: a randomised controlled trial
Acronym BABYLON trial
Scientific Title Effect of beta blockers for prevention of atrial fibrillation after CABG: a randomised controlled trial
Scientific Title:Acronym BABYLON trial
Region
Japan

Condition
Condition myocardial infarction, angina
Classification by specialty
Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the anti-arrhythmic effect of beta blockers in patients with atrial fibrillation after cardiac surgery
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes Incidence of postoperative atrial fibrillation
Key secondary outcomes 1) age
2) Blood pressure, heart rate, CVP
3) CK-MB, Tp-I, H-FABP
4) hs-CRP
5) ADMA
6) Pentraxin 3
7) mortality, complication
8) Ejection fraction (UCG), BNP
9) catecholamine

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration Institution is not considered as adjustment factor.
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 intra-and perioperative administration of landiolol hydrochloride (+)
postoperative administration of bisoprolol (+)
Interventions/Control_2 intra-and perioperative administration of landiolol hydrochloride (+)
postoperative administration of bisoprolol (-)
Interventions/Control_3 intra-and perioperative administration of landiolol hydrochloride (-)
postoperative administration of bisoprolol (-)
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
90 years-old >=
Gender Male and Female
Key inclusion criteria Patient undergoing isolated CABG
patients from whom informed consent was obtained
Key exclusion criteria past of arrhythmia
cardiogenic shock
NYHA class IV congestive heart failure despite treatment
sinus bradycardia at rest (<50/min)
second -or third-degree AV block
clinical hypothyroidism or hyperthyroidism
Doctor's decision not to register to this regimen
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akira Sezai
Organization Nihon University School of medicine
Division name Department of Cardiovascular Surgery
Zip code
Address 30-1 Oyaguchi kami-machi, Itabashi-ku, Tokyo, Japan
TEL 03-3982-8111
Email asezai.med@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Akira Sezai
Organization Nihon University School of Medicine
Division name Department of Cardiovascular Surgery
Zip code
Address 30-1 Oyaguchi kami-machi, Itabashi-ku, Tokyo, Japan
TEL 03-3972-8111
Homepage URL
Email asezai.med@gmail.com

Sponsor
Institute Nihon University school of medicine
Institute
Department

Funding Source
Organization Self funding
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

Other administrative information
Date of disclosure of the study information
2009 Year 09 Month 15 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
2009 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 06 Month 01 Day
Last follow-up date
2011 Year 12 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
2009 Year 09 Month 14 Day
Last modified on
2018 Year 03 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003052

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.