UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015241 |
|---|---|
| Receipt number | R000017712 |
| Scientific Title | A Pilot study for the effect of chronic BCAA (Branched-Chain Amino Acid) administration on perioperative patients underwent open-heart operation |
| Date of disclosure of the study information | 2014/09/30 |
| Last modified on | 2019/09/29 10:47:52 |
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Basic information
Public title
A Pilot study for the effect of chronic BCAA (Branched-Chain Amino Acid) administration on perioperative patients underwent open-heart operation
Acronym
Effectiveness of BCAA for cardiac surgery
Scientific Title
A Pilot study for the effect of chronic BCAA (Branched-Chain Amino Acid) administration on perioperative patients underwent open-heart operation
Scientific Title:Acronym
Effectiveness of BCAA for cardiac surgery
Region
| Japan |
Condition
Condition
Valvular heart disease
Classification by specialty
| Medicine in general | Cardiology | Operative medicine |
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of safety and efficacy of the BCAA for perioperative valvular heart disease patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Knee extension
Key secondary outcomes
Patients background (gender, age, complications, medical history, onset of heart failure), NYHA classification, blood exam (Hb, T-P, Alb, T-chol, TG, FBS, HbA1C, CK, BNP), urine chemistry (Cr, U-protein), cardiac function (echocardiography: LVEF (%), LVDd (mm), LVDs(mm))
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Intake Amino Care Jelly (Ajinomoto Co.Ltd)
Interventions/Control_2
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
Patients with valvular heart disease scheduled for valvular surgery in Kyushu University Hospital, Fukuoka, Japan.
Key exclusion criteria
Patients who have history of previous valvular surgery
Dialysis patients
eGFR<30 ml
who has allergy against apple
in case doctors find difficulties for the enrollment
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Tomomi |
| Middle name | |
| Last name | Ide |
Organization
Kyushu University
Division name
Department of Cardiovascular Medicine
Zip code
8128582
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka
TEL
092-641-1151
tomomi_i@cardiol.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomomi |
| Middle name | |
| Last name | Ide |
Organization
Kyushu University
Division name
Department of Cardiovascular Medicine
Zip code
812-8582
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka
TEL
092-642-5360
Homepage URL
tomomi_i@cardiol.med.kyushu-u.ac.jp
Sponsor or person
Institute
Tomomi Ide
Institute
Department
Personal name
Funding Source
Organization
Kyushu University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyushu University Hospital
Address
3-1-1, Maidashi, Higashiku, Fukuoka
Tel
81-92-642-5360
tomomi_i@cardiol.med.kyushu-u.ac.jp
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
九州大学病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 09 | Month | 30 | 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
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 09 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | Month | 02 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 09 | Month | 24 | Day |
Last modified on
| 2019 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017712
