UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Antiarrhythmic Effects of landiolol in cardiac surgery. Prospective study.
Title of the study (Brief title)	antiarrhythmic effect of landiolol in cardiac surgery
Region	Japan

Condition
Condition	aortic valve stenosis, aortic valve insufficiency, mitral valve stenosis, mitral valve insufficiency
Classification by specialty	Anesthesiology Cardiovascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To Evaluate of antiarrhytmic effects of landiol in cardiac surgery. 1st endpoints #1 postoperative atrial fibrillation (af) #2 intraoperative ventricular arrhythmia 2nd endpoints #3 postoperative mortality and morbidity #4 abnormality of blood chemistry, inflammatory, oxidative stress and ischemic response #5 hemodynamics during/after surgery #6 duration of hospitalization and ICU stay #7 incidence of arrhythmia after CPB(cardiopulmonary bypass)
Basic objectives2	Pharmacokinetics
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Incidence of postoperative af Incidence of arrhythmia after CPB
Key secondary outcomes	Complication and mortality after surgery hemodynamics during/after surgery duration of hospitalization and ICU stay abnormality of blood chemistry, inflammatory, oxidative stress and ischemic response duration of weaning of CPB

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	In landiolol treatment group, patients will be given landiolol intravenously during/after CPB. Landiolol will continuously administrate for 48 hours after begining of CPB.
Interventions/Control_2	On the other, in control group, patients will be given normal seline intravenously.
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	20 years-old <=
Age-upper limit	85 years-old >
Gender	Male and Female
Key inclusion criteria	1)aortic valve stenosis and/or aortic valve insufficiency 2)severity of aortic valve stenosis and/or aortic valve insufficiency are diagnosed as severe grade by preoperative echocardiography. 3)age limtation: 20 =/<, <85 years 4)all participants should obtain written informed consent of this study
Key exclusion criteria	1) emergency surgery 2) shock status before surgery 3) bradycardia (HR<50 bpm), 4) severe AV block 5)additional surgery (CABG, etc) 5) NYHA4 6) The patient who judged a doctor to be inappropriate as a subject
Target sample size	50

Research contact person
Name of lead principal investigator	Shinji Takahashi
Organization	University of Tsukuba
Division name	Faculty of medicine, department of Anesthesiology
Address	Tennodai1-1-1, Tsukuba, Ibaraki, JAPAN
TEL	029-853-3092
Email	shinjitk@md.tsukuba.ac.jp

Public contact
Name of contact person	Shinji Takahashi
Organization	University of Tsukuba
Division name	Faculty of medicine, department of Anesthesiology
Address	Tennodai1-1-1, Tsukuba, Ibaraki, JAPAN
TEL	029-853-3092
Homepage URL
Email	shinjitk@md.tsukuba.ac.jp

Sponsor
Institute	University of Tsukuba
Institute
Department

Funding Source
Organization	University of Tsukuba
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	筑波大学附属病院

Other administrative information
Date of disclosure of the study information	2017 Year 11 Month 06 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 11 Month 06 Day
Anticipated trial start date	2018 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 11 Month 06 Day
Last modified on	2017 Year 11 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033505