UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy and Safety of Add-on Branched-Chain Amino Acid in Cardiac Rehabilitation For Patients with Chronic Heart Failure
Title of the study (Brief title)	Efficacy and Safety of Add-on Branched-Chain Amino Acid in Cardiac Rehabilitation For Patients with Chronic Heart Failure
Region	Japan

Condition
Condition	Chronic Heart Failure
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The objective of this study is investigating about the effect of add-on BCAA on cardiopulmonary function, skeletal muscle function and metabolic state during cardiac rehabilitation. We also explore the effect of BCAA administration on these functions after cardiac rehabilitation.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Primary Endpoint the improvement of the work load at the point of anaerobic threshold
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Branched-Chain Amino Acid
Interventions/Control_2	control
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	65 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Inclusion Criteria Patient with chronic heart failure who participate in the cardiac rehabilitation program. age > 65 yo LVEF < 40 or LVEF > 40 and diastolic dysfunction(
Key exclusion criteria	Exclusion Criteria congenital disorders of amino acid metabolism inappropriate patient for cardiac rehabilitation pregnant or breast-feeding patient
Target sample size	48

Research contact person
Name of lead principal investigator	Amiya Eisuke
Organization	University of Tokyo Hospital
Division name	Cardiovascular Department
Address	Hongo 7-3-1, Bunkyo-ku, Tokyo, Japan
TEL	0338155411
Email	amiyae-tky@umin.ac.jp

Public contact
Name of contact person	Takata Munenori
Organization	University of Tokyo Hospital
Division name	Cardiovascular Department
Address	Hongo 7-3-1, Bunkyo-ku, Tokyo, Japan
TEL	0338155411
Homepage URL
Email	takatam-tky@umin.ac.jp

Sponsor
Institute	University of Tokyo Hospital
Institute
Department

Funding Source
Organization	scientific research fund
Organization
Division
Category of Funding Organization
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	2015 Year 11 Month 02 Day

Progress
Recruitment status	Recruiting
Date of protocol fixation	2015 Year 10 Month 02 Day
Anticipated trial start date	2015 Year 12 Month 01 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry	2019 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2015 Year 11 Month 02 Day
Last modified on	2017 Year 02 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022440