Unique ID issued by UMIN | UMIN000004488 |
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Receipt number | 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 15:34:02 |
Randomized evaluation of the beneficial effect of Livact in patients with heart failure complicated by hypoalbuminemia
Livact Heart Failure Trial
Randomized evaluation of the beneficial effect of Livact in patients with heart failure complicated by hypoalbuminemia
Livact Heart Failure Trial
Japan |
heart failure patients complicated by hypoalbuminemia
Cardiology |
Others
NO
To evaluate the beneficial effect of Livact for heart failure patients complicated by hypoalbuminemia
Safety,Efficacy
Exploratory
Pragmatic
Not applicable
Serum albumine
Cardiothoracic ratio (CTR)
Duration of admission, Hospitalization cost, Amount of food intake, Performance status, BNP, Amino acid fraction, Racio of mercapto albumin, Left ventricular ejection fraction
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
No treatment
YES
YES
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Medicine |
Intervention
Conventional therapy plus Livact 12g t.i.d.
4 weeks or until discharge
Control
Conventional therapy only
20 | years-old | <= |
Not applicable |
Male and Female
1)Hospitalized patients due to exacerbation of heart failure
2) Hypoalbuminemia in two discrete blood test during hospitalization
3) over 20 years old
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
40
1st name | |
Middle name | |
Last name | Masafumi Watanabe |
University of Tokyo Hospital
Department of Cardiovascular Medicine
Hongo 7-3-1, Bunkyo-ku, Tokyo, Japan
03-3815-5411
masafumi-tky@umin.net
1st name | |
Middle name | |
Last name | Masafumi Watanabe |
University of Tokyo Hospital
Department of Cardiovascular Medicine
Hongo 7-3-1, Bunkyo-ku, Tokyo, Japan
03-3815-5411
masafumi-tky@umin.net
University of Tokyo Hospital, Departement of Cardiovascular Medicine
Ajinomoto Pharmaceuticals Corporation
Profit organization
Japan
NO
2010 | Year | 11 | Month | 08 | Day |
Unpublished
No longer recruiting
2010 | Year | 11 | Month | 01 | Day |
2010 | Year | 11 | Month | 01 | Day |
2010 | Year | 11 | Month | 01 | Day |
2017 | Year | 05 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005368
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