UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003758 |
|---|---|
| Receipt number | R000004516 |
| Scientific Title | The effect of landiolol on postoperative arterial fibrillation in aortic stenosis patients undergoing aortic valve replacement |
| Date of disclosure of the study information | 2010/06/15 |
| Last modified on | 2012/03/21 12:22:17 |
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Basic information
Public title
The effect of landiolol on postoperative arterial fibrillation in aortic stenosis patients undergoing aortic valve replacement
Acronym
The effect of landiolol on postoperative arterial fibrillation in aortic stenosis patients undergoing aortic valve replacement
Scientific Title
The effect of landiolol on postoperative arterial fibrillation in aortic stenosis patients undergoing aortic valve replacement
Scientific Title:Acronym
The effect of landiolol on postoperative arterial fibrillation in aortic stenosis patients undergoing aortic valve replacement
Region
| Japan |
Condition
Condition
Patient with aortic valve stenosis undergoing isolated aortic valve replacement
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Arterial fibrillation occur in 10 to 40% of patients after cardiac surgery. Postoperative supraventricular arrhythmias have been shown to increase the risk of hospitalization and death in patients with cardiac surgery.
Landiolol have proven to be effective for arterial fibrillation after coronary artery bypass grafts. But there is no evidence after aortic valve replacement (AVR) with aortic valve stenosis (AS). Landiolol is an ultra short-acting beta-adrenergic receptor blocker that has a higher beta 1-selectivity(beta1/beta2=255) and a shorter elimination t1/2 (4min in healthy subjects) than any of the other currently available beta-adrenergic receptor blockers. We thought that landiolol would be suitable for intensive care unit patients due to its high beta 1-selectivity and rapid onset and offset of action.
We conducted a prospective, randomized trial of the effect of the beta-blocker landiolol on postoperative arterial fibrillation following AVR in AS patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence of arterial fibrillation on 7POD.
Key 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
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administer a dose of 0.005mg/kg/min of landiolol for 48 hours
Interventions/Control_2
Not administer beta-adrenergic antagonist to patients
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
Patient with aortic valve stenosis scheduled for isolated aortic valve replacement
Key exclusion criteria
Patients who is not candidates for beta-adrenergic antagonist therapy.
1 Preoperative LVEF<30%
2 COPD with FEV1.0<50%
3 Bronchial asthma(needs steroids or ronchodilating agents)
4 angina inversa
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tadanori Aizawa |
Organization
The Cardiovascular institute
Division name
cardiovascular internal medicine
Zip code
Address
3-10 Roppongi2-chome,Minato-ku,Tokyo
TEL
03-3408-2151
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshitaka Kadoma |
Organization
The Cardiovascular institute
Division name
surgery
Zip code
Address
3-10 Roppongi2-chome,Minato-ku,Tokyo
TEL
03-3408-2151
Homepage URL
kadoma@cvi.or.jp
Sponsor or person
Institute
The Cardiovascular institute
Institute
Department
Personal name
Funding Source
Organization
The Cardiovascular Institute
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
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
心臓血管研究所附属病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 06 | 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
Enrolling by invitation
Date of protocol fixation
| 2010 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 06 | Month | 15 | Day |
Last modified on
| 2012 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004516
