UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003851
Receipt No. R000004640
Scientific Title Curcumin against chronic heart failure using a novel drug-delivery system
Date of disclosure of the study information 2010/07/01
Last modified on 2013/01/05

* 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 Curcumin against chronic heart failure using a novel drug-delivery system
Acronym DDS-Curcumin CHF study
Scientific Title Curcumin against chronic heart failure using a novel drug-delivery system
Scientific Title:Acronym DDS-Curcumin CHF study
Region
Japan

Condition
Condition Hypertensive Heart Disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine whether high-absorptive 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 Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 High-absorptive Curcumin 60mg/day po for 24 weeks
Interventions/Control_2
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 50

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, Fushimiku,
TEL 075-641-9161
Email

Public contact
Name of contact person
1st name
Middle name
Last name Koji Hasegawa
Organization National Hospital Organization Kyoto
Division name Division of Translational Research
Zip code
Address 1-1 Mukaihata-cho, Fukakusa, Fushimiku,
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 The Japan Health Sciences Foundation
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
2010 Year 07 Month 01 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
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
2010 Year 06 Month 09 Day
Date of IRB
Anticipated trial start date
2010 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 07 Month 01 Day
Last modified on
2013 Year 01 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004640

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.