hypertensive cardiac hypertrophy hypertensive heart disease
Conditions
Interventions
Arm highly bioavailable curcumin: highly bioavailable curcumin capsule (curcumin 90mg/capsule), one capsule is given twice a day (morning and evening) for 48 weeks.
Arm Placebo: placebo capsule, one c
D003474
curcumin
Sponsors
Hasegawa Koji
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Average home systolic blood pressure for the four weeks prior to consent acquisition is less than 125 mmHg and condition is stable. Home blood pressure must be measured twice a day (morning and evening) for at least seven days in the four weeks prior to registration (measurements will be confirmed using a blood pressure diary or smartphone). The mean value will be calculated by averaging the systolic blood pressure for the most recent seven days (morning and evening, twice a day, a total of 14 times). A stable condition is defined as no change in medication content or amount for the six months ptior to registration. (2) An echocardiogram must meet all of the following criteria. a) Interventricular septum (IVS) or posterior wall thickness (PWT) of the left ventricle is 11 mm or greater b) Left ventricular ejection fraction (EF) of 60% or higher c) The core side ratio of the mitral inflow velocity and mitral annular velocity is 10 or higher. d) Decay time (DT) of 140 msec or more. (3) At the time of obtaining consent, age 40 years or older and under 65 years old , both gender. (4) ECOG PS (Performance Status) 0: Those whose daily lives are completely unaffected. (5) Normal sinus rhythm on resting ECG and blood BNP is less than 35pg/mL . (6) No history of hospitalization within 1 year prior to the date of consent. (7) Written informed consent is obtained.
Exclusion criteria
Exclusion criteria: (1) Subjects who have taken highly absorbable curcumin within the 3 months prior to enrollment. (2) Patients with secondary hypertension, poorly controlled diabetes (HbA1c is 8.0 or higher) or severe obesity (BMI is 35 or higher). (3) Subjects using Insulin, GLP-1 receptor agonists. (4) Subjects with a history of allergies to curcumin. (5) Subjects with a history of allergies to cornstarch. (6) Pregnant woman and those who are breastfeeding. (7) Patient with a history of atherosclerotic cardiovascular disease (stroke, myocardial infarction, coronary revascularization (bypass surgery or stent implantation), lower limb obstructive disease (previous revascularization or ABI is less than 0.6). (8) Subjects with a history of hospitalization for congestive heart failure. (9) Subjects with valvular disease or myocardial disease*. *On ecocardiography, left ventricular wall thickness (mid- or posterior wall) is 13mm or more, regurgitation of any cardiac valve is grade III/IV or more, or valve orifice area is less than 1.5 cm2. (10) Patients receiving medications with evidence for heart failure with preserved ejection fraction (ARNI, MRA, SGLT2 inhibitors) (11) Subjects using antithrombotic drugs (antiplatelet drugs, anticoagulants, EPA drugs, prostacyclin drugs) (12) Subjects who regularly intake or inject anti-inflammatory drugs, steroids, immunosuppressive drugs, or biological drugs. (13) Subjects receiving home oxygen therapy. (14) Subjects with severely impaired renal function (eGFR less than 30) (15) Subjects with severe hepatic dysfunction or cirrhosis (Grade C in Child-Pugh classification) (16) Subjects who are judged by the principal investigator or the sub-investigator to be inappropriate for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in blood BNP concentration after 48 weeks of test drug administration compared to before treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) The change in blood BNP concentration after 24 weeks of test drug administration compared to before treatment (2) Changes in the following values after 24 and 48 weeks of test drug administration compared to baseline. a) blood pressure, b) Cardio-Ankle-Vascular Index test values (CAVI), c) inflammatory biomarkers such as neutrophil to lymphocyte ratio and CRP. (3) Changes in echocardiographic indices after 24 and 48 weeks of test drug administration compared to baseline (E/e', E wave, A wave, E/A, LVIDd, LVIDs, LAD, IVSt, PWt). (4) Correlation between changes in blood BNP levels at 24 and 48 weeks after starting the test drug and changes in blood pressure, CAVI test results, inflammatory biomarkers, and echocardiographic indices (5) Adverse events | — |
Contacts
Public ContactKoji Hasegawa
National Hospital Organization Kyoto Medical Center
Outcome results
None listed