Curcumin Against Chronic Heart Failure Using a Novel Drug-Delivery System -Dose Finding Study

Phase 2

• Conditions: Hypertensive Heart Disease

• Registration Number: JPRN-UMIN000006227
• Lead Sponsor: ational Hospital Organization Kyoto Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-09-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

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) or planned (=< 6 months) AC bypass surgery / PCI 3) Severe arrhythmia(sustainedventricular 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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