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

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 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


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

Value
https://center6.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