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Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000003758
Receipt No. 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

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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
Email

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
Email kadoma@cvi.or.jp

Sponsor
Institute The Cardiovascular institute
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004516

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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