UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014232 |
|---|---|
| Receipt number | R000016575 |
| Scientific Title | Randomized double-blind study for the effect of highly absorptive curcumin on left ventricular diastolic function in hypertensive patients with hypertrophied hearts |
| Date of disclosure of the study information | 2014/06/11 |
| Last modified on | 2021/12/16 10:27:34 |
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Basic information
Public title
Randomized double-blind study for the effect of highly absorptive curcumin on left ventricular diastolic function in hypertensive patients with hypertrophied hearts
Acronym
Randomized double-blind study of highly absorptive curcumin in hypertensive patients with hypertrophied hearts
Scientific Title
Randomized double-blind study for the effect of highly absorptive curcumin on left ventricular diastolic function in hypertensive patients with hypertrophied hearts
Scientific Title:Acronym
Randomized double-blind study of highly absorptive curcumin in hypertensive patients with hypertrophied hearts
Region
| Japan |
Condition
Condition
Hypertensive Heart Disease
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine whether highly absorptive curcumin improves left ventricular hypertrophy and/or diastolic function in patients with hypertensive left ventricular hypertrophy with impaired diastolic function
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
Changes in left ventricular diastolic function estimated as E/E' by Doppler echocardiography for 24 weeks from the start of administration
Key secondary outcomes
(1) Plasma BNP levels
(2) Evaluation for the safety
1) Hematological and biochemical evaluation by blood examination, and urine examination
2) Others, adverse events
(3) Other evaluation items
1) Blood curcumin levels
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Highly absorptive curcumin 90mg/capsule x 2 capsules/day for 24 weeks
Interventions/Control_2
Placebo 2 capsules/day for 24 weeks
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
Stable hypertensive patients with left ventricular (LV) hypertrophy and moderate diastolic dysfunction should meet the following criteria.
(1) Past history of blood pressure more than 135/85 mmHg
(2) Echocardiographic findings of the patients should meet the following criteria
1) LV intraventricular septum thickness more than 11mm and/or LV posterior thickness more than 11mm
2) Mitral E/E' should be more than 10, and Deceleration time should be more than 140 msec.
3) LV ejection fraction by Simpson method is more than 60%
(3) Blood pressure should be stable; blood pressure less than 140/90 mmHg for 3 months or more
Compared with echocardiographic findings performed between 8 to 24 weeks before the administration of testing materials, changes in mitral E/E' should be within 20%
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) o planned (=< 6 months) AC bypass furgery/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) Severe liver dysfunction or liver cirrhosis
9) Renal failure (Cre >=4.0 mg/dL or dialysis)
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, nursin g or a wish for pregnancy within next 6 months
17) etc
Target sample size
230
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Hasegawa |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Division of Translational Research
Zip code
612-8555
Address
1-1 Mukaihatacho Fukakusa Fushimi-ku
TEL
075-641-9161
koj@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Hasegawa |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Division of Translational Research
Zip code
612-8555
Address
1-1 Mukaihatacho Fukakusa Fushimi-ku
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
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Theravalues Corporation
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee, National Hospital Organization Kyoto Medical Center
Address
1-1 Mukaihata-cho Fukakusa Kyoto
Tel
075-641-9161
ayasoda@kuhp.kyoto-u.ac.jp
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
| 2014 | Year | 06 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
No longer recruiting
Date of protocol fixation
| 2014 | Year | 03 | Month | 17 | Day |
Date of IRB
| 2014 | Year | 03 | Month | 17 | Day |
Anticipated trial start date
| 2014 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 02 | Month | 07 | Day |
Date trial data considered complete
| 2021 | Year | 10 | Month | 12 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 06 | Month | 11 | Day |
Last modified on
| 2021 | Year | 12 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016575
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