UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008472
Receipt number R000009040
Scientific Title Effect of perioperative randiolol administration on inhibiting postoperative Atrial Fibrillation.
Date of disclosure of the study information 2012/07/20
Last modified on 2012/07/19 12:11:53

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Basic information

Public title

Effect of perioperative randiolol administration on inhibiting postoperative Atrial Fibrillation.

Acronym

IDEAL study

Scientific Title

Effect of perioperative randiolol administration on inhibiting postoperative Atrial Fibrillation.

Scientific Title:Acronym

IDEAL study

Region

Japan


Condition

Condition

Patients with preoperative EFs 40% or less who undergo cardiovascular operations using cariopulmonary bypass machine or Off Pump CABG (OPCAB) in the Department of Cardiovascular Surgery, Osaka University Hospital.

Classification by specialty

Cardiovascular surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify whether landiolol can also be safely used in patients with left ventricular dysfunction and is useful for the prevention of postoperative atrial fibrillation.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

occurrence of postopeartive atrial fibrillation

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Medicine

Interventions/Control_1

administration of landiolol

Interventions/Control_2


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

Patients without preoperative chronic atrial fibrillation.

Key exclusion criteria

1. Patients with cardiogenic shock
2. Patients with diabetic ketoacidosis and metabolic acidosis
3. Patients with bradycardia such as atrioventricular block (II degree or higher) and sick sinus syndrome
4. Patients with right heart failure due to pulmonary hypertension
5. Patients with congestive heart failure
6. Patients with untreated pheochromocytoma
7. Patients with a past history of hypersensitivity to landiolol
8. Patients with congenital heart diseases
9. Patients undergoing heart transplantation
10. Patients with ventricular assisted devices
11. Patients with ECMO
12. Patients having atrial fibrillation immediately before administration of landiolol

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshiki Sawa

Organization

Osaka University Graduate School of Medicine

Division name

Department of Cardiovascular Surgery

Zip code


Address

2-2, Yamada-Oka, Suita, Osaka, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Osaka University Graduate School of Medicine

Division name

Department of Cardiovascular Surgery

Zip code


Address


TEL


Homepage URL


Email

nishi24@jc4.so-net.ne.jp


Sponsor or person

Institute

Osaka University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Osaka University Graduate School of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



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



Other administrative information

Date of disclosure of the study information

2012 Year 07 Month 20 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

Open public recruiting

Date of protocol fixation

2012 Year 06 Month 01 Day

Date of IRB


Anticipated trial start date

2012 Year 07 Month 20 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

2012 Year 07 Month 19 Day

Last modified on

2012 Year 07 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009040


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name