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

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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 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


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

Value
https://center6.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