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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000023944
Receipt No. 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

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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
Email 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
Email hyamamoto@chibanishi-hp.or.jp

Sponsor
Institute Chiba-Nishi General Hospital

Cardiology
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027571

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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