Hypertensive Heart Disease
Conditions
Interventions
Highly absorptive curcumin 90mg/capsule x 2 capsules/day for 24 weeks
Placebo 2 capsules/day for 24 weeks
Sponsors
National Hospital Organization Kyoto Medical Center
Theravalues Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
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%
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in left ventricular diastolic function estimated as E/E' by Doppler echocardiography for 24 weeks from the start of administration | — |
Secondary
| Measure | Time frame |
|---|---|
| (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 | — |
Countries
Japan
Contacts
Public ContactKoji Hasegawa
National Hospital Organization Kyoto Medical Center Division of Translational Research
Outcome results
None listed