UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019601 |
|---|---|
| Receipt number | R000022440 |
| Scientific Title | Efficacy and Safety of Add-on Branched-Chain Amino Acid in Cardiac Rehabilitation For Patients with Chronic Heart Failure |
| Date of disclosure of the study information | 2015/11/02 |
| Last modified on | 2017/02/19 22:10:43 |
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Basic information
Public title
Efficacy and Safety of Add-on Branched-Chain Amino Acid in Cardiac Rehabilitation For Patients with Chronic Heart Failure
Acronym
Efficacy and Safety of Add-on Branched-Chain Amino Acid in Cardiac Rehabilitation For Patients with Chronic Heart Failure
Scientific Title
Efficacy and Safety of Add-on Branched-Chain Amino Acid in Cardiac Rehabilitation For Patients with Chronic Heart Failure
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Amiya Eisuke |
Organization
University of Tokyo Hospital
Division name
Cardiovascular Department
Zip code
Address
Hongo 7-3-1, Bunkyo-ku, Tokyo, Japan
TEL
0338155411
amiyae-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takata Munenori |
Organization
University of Tokyo Hospital
Division name
Cardiovascular Department
Zip code
Address
Hongo 7-3-1, Bunkyo-ku, Tokyo, Japan
TEL
0338155411
Homepage URL
takatam-tky@umin.ac.jp
Sponsor or person
Institute
University of Tokyo Hospital
Institute
Department
Personal name
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)
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 02 | 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
Date of protocol fixation
| 2015 | Year | 10 | Month | 02 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022440
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| Registered date | File name |
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