UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023572 |
|---|---|
| Receipt number | R000027148 |
| Scientific Title | Impact of exercise training in combination with essential amino acid containing food on skeletal muscle volume and strength in patients with heart failure. |
| Date of disclosure of the study information | 2016/08/20 |
| Last modified on | 2018/12/28 15:15:09 |
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Basic information
Public title
Impact of exercise training in combination with essential amino acid containing food on skeletal muscle volume and strength in patients with heart failure.
Acronym
CVI-ARO 11 study
Scientific Title
Impact of exercise training in combination with essential amino acid containing food on skeletal muscle volume and strength in patients with heart failure.
Scientific Title:Acronym
CVI-ARO 11 study
Region
| Japan |
Condition
Condition
Chronic heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to seek whether essentail amino-acid supplementation improves effectively the reduced skeletal muscle volume and strength in patients with heart failure
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Thigh muscle volume and strength
Key secondary outcomes
BNP(brain natriuretic peptide), variables obtained by echocardiography, QOL, exercise capacity)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
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
| Food |
Interventions/Control_1
taking essential amino acid containing food every day for 3 months and exercise training
Interventions/Control_2
exercise training only
;aerobic exercise and strength training
for 3 months
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
diagnosed as chronic heart failure
be able to take the food orally
be able to attend the supervised cardiac rehabilitation program at least once a week.
Key exclusion criteria
under hemodialysis
severe valvular stenosis
orthopedic disease which do not allow exercise training
food allergy especially for apple
already taking medicine containing BCAA
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuko Kato |
Organization
The Cardiovascular Institute
Division name
Cardiovascular medicine
Zip code
Address
3-2-19, Nishiazabu, Minato-ku, Tokyo, Japan
TEL
0334082151
kimuchi@nms.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazumi Matsuda |
Organization
The Cardiovascular Institute
Division name
Office
Zip code
Address
0334082151
TEL
0334082151
Homepage URL
matsuda@cvi.or.jp
Sponsor or person
Institute
CVI ARO
Institute
Department
Personal name
Funding Source
Organization
Ajinomoto CO., Inc
Organization
Division
Category of Funding Organization
Profit 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
| 2016 | Year | 08 | Month | 20 | 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
Completed
Date of protocol fixation
| 2016 | Year | 07 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
| 2017 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2018 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 08 | Month | 09 | Day |
Last modified on
| 2018 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027148
