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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000004488
Receipt No. R000005368
Scientific Title Randomized evaluation of the beneficial effect of Livact in patients with heart failure complicated by hypoalbuminemia
Date of disclosure of the study information 2010/11/08
Last modified on 2017/05/19

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Basic information
Public title Randomized evaluation of the beneficial effect of Livact in patients with heart failure complicated by hypoalbuminemia
Acronym Livact Heart Failure Trial
Scientific Title Randomized evaluation of the beneficial effect of Livact in patients with heart failure complicated by hypoalbuminemia
Scientific Title:Acronym 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
1st name
Middle name
Last name Masafumi Watanabe
Organization University of Tokyo Hospital
Division name Department of Cardiovascular Medicine
Zip code
Address Hongo 7-3-1, Bunkyo-ku, Tokyo, Japan
TEL 03-3815-5411
Email masafumi-tky@umin.net

Public contact
Name of contact person
1st name
Middle name
Last name Masafumi Watanabe
Organization University of Tokyo Hospital
Division name Department of Cardiovascular Medicine
Zip code
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)

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
2010 Year 11 Month 08 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 No longer recruiting
Date of protocol fixation
2010 Year 11 Month 01 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000005368

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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