UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023944 |
|---|---|
| Receipt number | R000027571 |
| Scientific Title | Best Beta-Blocker in Systolic Heart Failure, analysis of prognosis and evaluation of therapies |
| Date of disclosure of the study information | 2016/09/07 |
| Last modified on | 2016/09/06 03:31:58 |
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Basic information
Public title
Best Beta-Blocker in Systolic Heart Failure, analysis of prognosis and evaluation of therapies
Acronym
B-cube SHF trial
Scientific Title
Best Beta-Blocker in Systolic Heart Failure, analysis of prognosis and evaluation of therapies
Scientific Title:Acronym
B-cube SHF trial
Region
| Japan |
Condition
Condition
systolic heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aim to compare the effects of bisoprolol and carvedilol on clinical outcome of chronic systolic heart failure patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The composite endpoint of major adverse cardiac events (MACEs) OR rehospitalization for heart failure
Key secondary outcomes
safety
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
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Bisoprolol group
Daily oral administration of bisoprolol 0.625 mg tablet once a day should be given.
If tolerability is confirmed by an investigator, the dose should be increased to 1.25 mg.
In the same manner, the doses should be increased to 2.5 mg, to 3.75 mg, and to 5 mg.
Interventions/Control_2
Carvedilol group
Daily oral administration of bisoprolol 2.5mg tablet once a day should be given.
If tolerability is confirmed by an investigator, the dose should be increased to 5 mg.
In the same manner, the doses should be increased to 10 mg, to 15 mg, and to 20 mg.
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
1) primary disease: in principle, ischemic heart disease or dilated cardiomyopathy.
2) heart failure patients with 40% or less of left ventricular ejection fraction (LVEF). any NYHA class.
3) basic treatment: in principle, patients undergoing treatment with an ACE inhibitor(or ARB) OR a diuretic.
4) patients who had not undergone treatment with a beta-blocker (except eye drops) within 8 weeks before the registration date.
5) age: patient aged 20 to less than 85 on the day of obtaining written informed consent.
6) hospitalized/outpatient: either hospitalized or outpatient status.
7) gender: male of female
8) patients who had a detailed briefing of the trial with explanatory documents prior to the enrollment and voluntarily signed a consent form.
Key exclusion criteria
1) patients who are considered not to be candidate for administration of beta blocker.
2) patients who are scheduled to undergo emergent dialysis or chronic dialysis patients.
3) patients who have developed acute coronary syndrome within 8 weeks before the registration day.
4) patients who need mechanical hemodynamical support (except for pace maker implantation OR ICD)
5) patients who have malignancy within 1 year prognosis.
6) patients who are pregnant, lactating, may become pregnant, or want to become pregnant during the study.
7) patients who are judged by an investor to be inappropriate for this study for any other reason.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Yamamoto |
Organization
Chiba-Nishi General Hospital
Division name
Cardiology
Zip code
Address
107-1 Kanegasaku Matsudo-shi Chiba 270-2251 Japan
TEL
047-384-8229
hyamamoto@chibanishi-hp.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Yamamoto |
Organization
Chiba-Nishi General Hospital
Division name
Cardiology
Zip code
Address
107-1 Kanegasaku Matsudo-shi Chiba 270-2251 Japan
TEL
047-384-8229
Homepage URL
hyamamoto@chibanishi-hp.or.jp
Sponsor or person
Institute
Chiba-Nishi General Hospital
Cardiology
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
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
千葉西総合病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 09 | Month | 07 | 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
Terminated
Date of protocol fixation
| 2016 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 08 | Month | 10 | Day |
Date of closure to data entry
| 2016 | Year | 09 | Month | 05 | Day |
Date trial data considered complete
| 2016 | Year | 09 | Month | 06 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 09 | Month | 06 | Day |
Last modified on
| 2016 | Year | 09 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027571
