Unique ID issued by UMIN | UMIN000006227 |
---|---|
Receipt number | R000007369 |
Scientific Title | Curcumin Against Chronic Heart Failure Using a Novel Drug-Delivery System -Dose Finding Study- |
Date of disclosure of the study information | 2011/09/01 |
Last modified on | 2013/08/26 16:57:16 |
Curcumin Against Chronic Heart Failure Using a Novel Drug-Delivery System -Dose Finding Study-
DDS-Curcumin CHF Dose Finding Study
Curcumin Against Chronic Heart Failure Using a Novel Drug-Delivery System -Dose Finding Study-
DDS-Curcumin CHF Dose Finding Study
Japan |
Hypertensive Heart Disease
Cardiology |
Others
NO
To determine whether high-absorptive
curcumin improves left ventricular
diastolic function in patients with
hypertensive left ventricular hypertrophy
Efficacy
Exploratory
Explanatory
Phase II
Conventional Doppler indices of left
ventricular diastolic function including
1) Transmitral E/A ratio,
2) Decerelation time,
3) Pulmonary venous S/D ratio, etc
Tissue Doppler indices of left ventricular diastolic function including
4) E/E' ratio, etc
1) Symptons
2) Activity (Mets)
3) Blood pressure, pulse rate, and body
mass index
4) Blood analysis including BNP concentration and urinalysis
5) Plasma Curcumin concentration
6) Chest X-p
7) Electrocardiogram
8) Echocardiography: left ventricular (LV) end-diastolic dimension, LV end-systolic demension, LV ejection fraction, left atrial demension, intraventricular septum thickness, LV posterior wall thickness, transmitral E and A wave velosity, pulmonary S and D wave velosity, and tissue Doppler early diastolic mitral annular velosity, etc
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Food |
High-absorptive Curcumin 180mg/day
po for 24 weeks
20 | years-old | <= |
80 | years-old | > |
Male and Female
1) Stable hypertensive patients: blood
pressure =< 140/90 mmHg for a month
or more
2) Hypertensive patients with left
ventricular (LV) hypertrophy: past history of blood pressure >= 135/85 mmHg, andLV intraventricular septum thickness >=11mm and/or LV posterior wall thickness>= 11mm, and LV ejection fraction >=50% by echocardiograhy
1) Chronic atrial fibrillation
2) Unstable angina, recent (< 3 months)
myocardial infarction, severe coronary
heart disease (left main trunk or 3 vessel disease), and recent (=< 3 months) or planned (=< 6 months) AC bypass surgery / PCI
3) Severe arrhythmia(sustainedventricular tachycardia, ventricular fibrillation, and severe bradycardia with an indication of pacemaker implantation
4) Moderate or severe valvular diseases
5) Cardiomyopathy or progressive
myocarditis
6) Severe respiratory diseases
7) Cardiogenic shock or systolic blood
pressure < 80 mmHg
8) Renal failure (Cre >= 4.0 mg/dL or
dialysis)
9) Severe liver dysfunction or liver
cirrhosis
10) Recent (< 3 months) cerebrovascular
disease
11) Malignancy
12) Poorly controlled diabetes (HbA1c >=
8.0%)
13) Anemia (Hb < 6.0 mg/dL)
14) Use of steroid
15) Past history of Curcumin allergy
16) Pregnancy, nursing, or a wish for
pregnancy within 6 months
17) etc
50
1st name | |
Middle name | |
Last name | Koji Hasegawa |
National Hospital Organization Kyoto Medical Center
Division of Translational Research
1-1 Mukaihata-cho, Fukakusa, Fushimiku,
075-641-9161
koj@kuhp.kyoto-u.ac.jp
1st name | |
Middle name | |
Last name | Koji Hasegawa |
National Hospital Organization Kyoto
Division of Translational Research
1-1 Mukaihata-cho, Fukakusa, Fushimiku, Kyoto, Japan
075-641-9161
koj@kuhp.kyoto-u.ac.jp
National Hospital Organization Kyoto
Medical Center
Theravalues corporation
Profit organization
NO
2011 | Year | 09 | Month | 01 | Day |
Unpublished
Completed
2011 | Year | 06 | Month | 06 | Day |
2011 | Year | 09 | Month | 01 | Day |
2011 | Year | 08 | Month | 24 | Day |
2013 | Year | 08 | Month | 26 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007369
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