UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031538
Receipt number R000036010
Scientific Title A comparative study of oral and percutaneous bisoprolol
Date of disclosure of the study information 2018/03/01
Last modified on 2020/01/28 22:57:42

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Basic information

Public title

A comparative study of oral and percutaneous bisoprolol

Acronym

A comparative study of oral and percutaneous bisoprolol

Scientific Title

A comparative study of oral and percutaneous bisoprolol

Scientific Title:Acronym

A comparative study of oral and percutaneous bisoprolol

Region

Japan


Condition

Condition

Chronic heart failure, Hypertension

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Investigate the effect of oral and percutaneous bisoprolol on hemodynamics

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Herat rate (Holter ECG)

Key secondary outcomes

BNP
Blood pressure
UCG


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Non-randomized

Randomization unit


Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Oral bisoprolol (1.25 to 5 mg, once / day, 6 months)

Interventions/Control_2

percutaneous bisoprolol (2 to 8 mg, once / day, 6 months)

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

100 years-old >

Gender

Male and Female

Key inclusion criteria

Chronic heart failure or hypertensive patient

Key exclusion criteria

sinus bradycardia at rest (<50/min)
second -or third-degree AV block
Doctor's decision not to register to this regimen

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Akira
Middle name
Last name Sezai

Organization

Nihon University school of medicine

Division name

Department of Cardiovascular Surgery

Zip code

1710014

Address

30-1 Oyagichi kami-machi, Itabashi-ku, Tokyo

TEL

03-3972-8111

Email

asezai.med@gmail.com


Public contact

Name of contact person

1st name Mitsue
Middle name
Last name Akiyama

Organization

Sekino Laboratory

Division name

Department of Research

Zip code

1710014

Address

3-28-3 ikebukuro, Toshima-ku, Tokyo, Japan

TEL

03-3986-5501

Homepage URL


Email

skn-np@sekino-hospital.com


Sponsor or person

Institute

Sekino Hospital

Institute

Department

Personal name



Funding Source

Organization

self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Nihon University Itashi Hospital

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Sekino Laboratory

Address

3-28-3 ikebukuro, Toshima-ku, Tokyo, Japan

Tel

03-3986-5501

Email

skn-np@sekino-hospital.com


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

関野病院(東京都)


Other administrative information

Date of disclosure of the study information

2018 Year 03 Month 01 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

50

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

Completed

Date of protocol fixation

2018 Year 02 Month 01 Day

Date of IRB

2018 Year 02 Month 01 Day

Anticipated trial start date

2018 Year 02 Month 10 Day

Last follow-up date

2020 Year 01 Month 10 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 03 Month 01 Day

Last modified on

2020 Year 01 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036010


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name