UMIN-CTR Clinical Trial

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
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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
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Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
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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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