Natural Compound Curcumin as a Novel Therapy for Congestive Heart Failure: Effects of Curcumin on Left Ventricular Diastolic Function in Hypertensive Heart Disease

UMIN ID: UMIN000002098

Registered date:31/07/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Hypertensive Heart Disease
• Date of first enrollment: 2009/08/01
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Curcumin 2g/day p.o.
Placebo 2g/day p.o.

Outcome(s)

• Primary Outcome: 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
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: National Hospital Organization Kyoto Medical Center
• Source(s) of Monetary Support: National Hospital Organization