UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Teruo Inoue
Organization	Dokkyo Medical University
Division name	Department of Cardiovascular Medicine
Address	880 Kitakobayashi Mibu Tochigi
TEL	0282-86-1111
Email	inouet@dokkyomed.ac.jp

Public contact
Name of contact person	Shigeru Toyoda
Organization	Dokkyo Medical University
Division name	Department of Cardiovascular Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 07 Month 13 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000013198