UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002098 |
|---|---|
| Receipt number | R000002560 |
| Scientific Title | Natural Compound Curcumin as a Novel Therapy for Congestive Heart Failure: Effects of Curcumin on Left Ventricular Diastolic Function in Hypertensive Heart Disease |
| Date of disclosure of the study information | 2009/07/31 |
| Last modified on | 2012/06/20 11:42:20 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Natural Compound Curcumin as a Novel Therapy for Congestive Heart Failure: Effects of Curcumin on Left Ventricular Diastolic Function in Hypertensive Heart Disease
Acronym
Curcumin for Hypertensive Heart Disease
Scientific Title
Natural Compound Curcumin as a Novel Therapy for Congestive Heart Failure: Effects of Curcumin on Left Ventricular Diastolic Function in Hypertensive Heart Disease
Scientific Title:Acronym
Curcumin for Hypertensive Heart Disease
Region
| Japan |
Condition
Condition
Hypertensive Heart Disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine whether curcumin improves left ventricular diastolic function in patients with hypertensive left ventricular hypertrophy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
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
Key secondary outcomes
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
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Curcumin 2g/day p.o.
Interventions/Control_2
Placebo 2g/day p.o.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
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, and LV intraventricular septum thickness >= 11mm and/or LV posterior wall thickness >= 11mm, and LV ejection fraction >= 50% by echocardiograhy
Key exclusion criteria
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 (sustained ventricular 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
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koji Hasegawa |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Division of Translational Research
Zip code
Address
1-1 Mukaihata-cho, Fukakusa, Fushimi-ku, Kyoto, Japan
TEL
075-641-9161
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koji Hasegawa |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Division of Translational Research
Zip code
Address
1-1 Mukaihata-cho, Fukakusa, Fushimi-ku, Kyoto, Japan
TEL
075-641-9161
Homepage URL
koj@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
National Hospital Organization Kyoto Medical Center
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2009 | Year | 07 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Tatsuya Morimoto, Hiromichi Wada, Yoichi Sunagawa, Masatoshi Fujita, Hideaki Kakeya, Atsushi Imaizumi, Tadashi Hashimoto, Masaharu Akao, Yasufumi Katanasaka, Genta Osakada, Hirofumi Kambara, Hiroki Shiomi, Takeshi Kimura, Akira Shimatsu, Koji Hasegawa.
Highly Absorptive Curcumin Improves Left
Ventricular Diastolic Function Regardless of Blood Pressure in Hypertensive Patients. The American College of Cardiology 61st Annual Scientific Session and ACC-i2 with TCT Chicago, USA 2012 March 24-27
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
Completed
Date of protocol fixation
| 2009 | Year | 06 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2012 | Year | 02 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 06 | Month | 20 | Day |
Last modified on
| 2012 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002560
