UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized evaluation of the beneficial effect of Livact in patients with heart failure complicated by hypoalbuminemia
Title of the study (Brief title)	Livact Heart Failure Trial
Region	Japan

Condition
Condition	heart failure patients complicated by hypoalbuminemia
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the beneficial effect of Livact for heart failure patients complicated by hypoalbuminemia
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Serum albumine Cardiothoracic ratio (CTR)
Key secondary outcomes	Duration of admission, Hospitalization cost, Amount of food intake, Performance status, BNP, Amino acid fraction, Racio of mercapto albumin, Left ventricular ejection fraction

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
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	Intervention Conventional therapy plus Livact 12g t.i.d. 4 weeks or until discharge
Interventions/Control_2	Control Conventional therapy only
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	1)Hospitalized patients due to exacerbation of heart failure 2) Hypoalbuminemia in two discrete blood test during hospitalization 3) over 20 years old
Key exclusion criteria	1) Renal dysfunction (BUN over 40mg/dl or Cre over 2.0mg/dl 2) Nephrotic syndrome, or urine protein over 3+ 3) HbA1c over 8.0% 4) Liver cirrhosis 5) Patients with malignancy 6) Patients with abnormal branched-chain amino acid metabolism 7) Ventricular arrhythmia 8) Patients who need ventilator support. 9) Severe infectious disease 10) Patients who are enrolled in another clinical trial
Target sample size	40

Research contact person
Name of lead principal investigator	Masafumi Watanabe
Organization	University of Tokyo Hospital
Division name	Department of Cardiovascular Medicine
Address	Hongo 7-3-1, Bunkyo-ku, Tokyo, Japan
TEL	03-3815-5411
Email	masafumi-tky@umin.net

Public contact
Name of contact person	Masafumi Watanabe
Organization	University of Tokyo Hospital
Division name	Department of Cardiovascular Medicine
Address	Hongo 7-3-1, Bunkyo-ku, Tokyo, Japan
TEL	03-3815-5411
Homepage URL
Email	masafumi-tky@umin.net

Sponsor
Institute	University of Tokyo Hospital, Departement of Cardiovascular Medicine
Institute
Department

Funding Source
Organization	Ajinomoto Pharmaceuticals Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2010 Year 11 Month 08 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2010 Year 11 Month 01 Day
Anticipated trial start date	2010 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2010 Year 11 Month 01 Day
Last modified on	2017 Year 05 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000005368