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
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
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
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
