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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023572
Receipt No. 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

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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
Email 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
Email matsuda@cvi.or.jp

Sponsor
Institute CVI ARO
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027148

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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