UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011261
Receipt number R000013198
Scientific Title Comparison of the effects of two beta blockers, bisoprolol and carvedilol on chronic heart failure Bisoprolol Improvement Group for Chronic Heart Failure Treatment Study in Dokkyo Medical University:BRIGHT-D
Date of disclosure of the study information 2013/07/24
Last modified on 2018/10/13 11:58:41

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Basic information

Public title

Comparison of the effects of two beta blockers, bisoprolol and carvedilol on chronic heart failure
Bisoprolol Improvement Group for Chronic Heart Failure Treatment Study in Dokkyo Medical University:BRIGHT-D

Acronym

Comparison of the effects of two beta blockers, bisoprolol and carvedilol on chronic heart failure

Scientific Title

Comparison of the effects of two beta blockers, bisoprolol and carvedilol on chronic heart failure
Bisoprolol Improvement Group for Chronic Heart Failure Treatment Study in Dokkyo Medical University:BRIGHT-D

Scientific Title:Acronym

Comparison of the effects of two beta blockers, bisoprolol and carvedilol on chronic heart failure

Region

Japan


Condition

Condition

Chronic Heart Failure

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Comparison of the effects and safety of Bisoprolol with Carvedilol in Japanese patients with chronic heart failure

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Re-hospitalization in 2 years follow up

Key secondary outcomes

Evaluation of cardiac function and biomarkers(hs TnT, NT-proBNP etc)


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Bisoprolol 0.625-5mg/day
Once a day,24weeks<

Interventions/Control_2

Carvedolol 2.5-20mg/day
Twice a day,24weeks<

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

Chronic heart failure patients with <45% ejection fraction, who had received intensive medications(RAS inhibitor ,
Diuretics) except Beta blockers, and stable symptom for 1-2 month before enrollment of this study.

Key exclusion criteria

NYHA grade 4
Serious arrythmia
Bradycardia(60 beats/min>)
AV block(grade 2<)
Hypotension(resting SBP<90mmHg)
Asthma, Bronchospasm
Hepatic dysfunciton, Renal insufficiency

Target sample size

75


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Teruo Inoue

Organization

Dokkyo Medical University

Division name

Department of Cardiovascular Medicine

Zip code


Address

880 Kitakobayashi Mibu Tochigi

TEL

0282-86-1111

Email

inouet@dokkyomed.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shigeru Toyoda

Organization

Dokkyo Medical University

Division name

Department of Cardiovascular Medicine

Zip code


Address

880 Kitakobayashi Mibu Tochigi

TEL

0282-86-1111

Homepage URL


Email

s-toyoda@dokkyomed.ac.jp


Sponsor or person

Institute

Dokkyo Medical University Department of Cardiovascular Medicine

Institute

Department

Personal name



Funding Source

Organization

None

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

2013 Year 07 Month 24 Day


Related information

URL releasing protocol


Publication of results

Partially published


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

Completed

Date of protocol fixation

2010 Year 07 Month 13 Day

Date of IRB


Anticipated trial start date

2010 Year 07 Month 26 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

2013 Year 07 Month 24 Day

Last modified on

2018 Year 10 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013198


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name