UMIN-CTR Clinical Trial

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
Email	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
Email	tomomi_i@cardiol.med.kyushu-u.ac.jp

Sponsor
Institute	Tomomi Ide
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017712