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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002098
Receipt No. 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

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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
Email

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
Email koj@kuhp.kyoto-u.ac.jp

Sponsor
Institute National Hospital Organization Kyoto Medical Center
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002560

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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