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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011261
Receipt No. 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

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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
Last 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
1st 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
Institute Dokkyo Medical University Department of Cardiovascular Medicine
Institute
Department

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
URL(English) https://upload.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


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