UMIN-CTR Clinical Trial

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
Email	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
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	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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016575