UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Best Beta-Blocker in Systolic Heart Failure, analysis of prognosis and evaluation of therapies
Title of the study (Brief title)	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	Hiroyuki Yamamoto
Organization	Chiba-Nishi General Hospital
Division name	Cardiology
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	Hiroyuki Yamamoto
Organization	Chiba-Nishi General Hospital
Division name	Cardiology
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 06 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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