UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004216 |
|---|---|
| Receipt number | 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 | 2023/03/26 10:56:12 |
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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 | TEIJI |
| Middle name | |
| Last name | Oda |
Organization
Shimane University Faculty of Medicine
Division name
Department of Cardiovascular and Thoracic Surgery
Zip code
693-8501
Address
89-1 Enya-cho, Izumo, Shimane 693-8501, Japan
TEL
0853202223
toda@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuma |
| Middle name | |
| Last name | Kanetsuki |
Organization
Shimane University Faculty of Medicine
Division name
Department of Cardiovascular and Thoracic Surgery
Zip code
693-8501
Address
89-1 Enya-cho, Izumo, Shimane 693-8501, Japan
TEL
0853202223
Homepage URL
kkazuma@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University Faculty of Medicine
Institute
Department
Personal name
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
The Shimane University Institutional Committe
Address
89-1 Enya-cho, Izumo, Shimane 693-8501, Japan
Tel
0853-20-2515
Kenkyu@med.shimane-u.ac.jp
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
| 2023 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005063
