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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000004216
Receipt No. R000005063
Scientific Title Efficacy of beta-blocker on the autonomic nervous activities and the onset of atrial fibrillation or flutter in patients after cardiac surgery.
Date of disclosure of the study information 2010/10/01
Last modified on 2017/03/21

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Basic information
Public title Efficacy of beta-blocker on the autonomic nervous activities and the onset of atrial fibrillation or flutter in patients after cardiac surgery.
Acronym Impact of beta-blocker on autonomic nervous activities and onset of atrial fibrillation/flutter following cardiac surgery.
Scientific Title Efficacy of beta-blocker on the autonomic nervous activities and the onset of atrial fibrillation or flutter in patients after cardiac surgery.
Scientific Title:Acronym Impact of beta-blocker on autonomic nervous activities and onset of atrial fibrillation/flutter following cardiac surgery.
Region
Japan

Condition
Condition Atrial fibrillation or flutter following cardiac surgery
Classification by specialty
Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aims of this study are to clarify the relationships of autonomic nerve activities and the onset of atrial fibrillation/flutter in patients after cardiac surgery, and to evaluate the efficacy of beta blockers on atrial fibrillation/flutter following cardiac surgery
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes This study is a randomized open-label controlled trial. An ultra-short acting beta- blocker (landiolol hydrochloride) is intravenously given immediately after cardiac surgery, followed by oral carvedilol in the patients randomized to treatment group. The incidence of postoperative atrial fibrillation / flutter during 7days after operation is evaluated as a major outcome.
Key secondary outcomes The autonomic changes are evaluated by the analysis of heart rate variability (Holter recording analysis) as secondary outcomes.

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Intravenous landiolol hydrochloride administration (5 mirogram/Kg/min, given immediately after cardiac surgery up to 2 days after initiation of administration of carvedilol)
Oral carvedilol administration (2.5 mg/day, up to 7 days after cardiac surgery)
Interventions/Control_2 non-administration of landiolol
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients undergoing cardiac surgery
Key exclusion criteria 1. Patients with chronic or paroxysmal atrial fibrillation
2. Patients receiving antiarrhythmic agents: Ia, IIc and IV groups
3. Patients with sick sinus syndrome
4. Patients with higher than 2 degree atrioventricular block
5. Heart failure patients with EF less than 30%
6. Patients with bronchial asthma
7. Patients receiving beta blockers
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Teiji Oda
Organization Shimane University Faculty of Medicine
Division name Department of Cardiovascular and Thoracic Surgery
Zip code
Address 89-1 Enya-cho, Izumo, Shimane 693-8501, Japan
TEL 0853-20-2223
Email toda@med.shimane-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuma Kanetsuki
Organization Shimane University Faculty of Medicine
Division name Department of Cardiovascular and Thoracic Surgery
Zip code
Address 89-1 Enya-cho, Izumo, Shimane 693-8501, Japan
TEL 9853-20-2224
Homepage URL
Email kkazuma@med.shimane-u.ac.jp

Sponsor
Institute Shimane University Faculty of Medicine
Institute
Department

Funding Source
Organization Shimane University Faculty of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization None

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

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 島根大学医学部附属病院(島根県)

Other administrative information
Date of disclosure of the study information
2010 Year 10 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 Enrolling by invitation
Date of protocol fixation
2009 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 11 Month 01 Day
Last follow-up date
2011 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 09 Month 15 Day
Last modified on
2017 Year 03 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005063

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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