chronic ischemic heart failure
Conditions
Interventions
Shexiang Baoxin Pill:optimal western medcine + Shexiang Baoxin Pill(2 pills,tid,po.),24 weeks
placebo:optimal westen medcine + placebo (2 pills, tid, po.), 24weeks
Sponsors
Shanghai Changzheng Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Able and willing to provide signed informed consent; 2. Age >=18; 3. History or symptoms of chronic heart failure exist at least 3 months before enrollment; 4. The etiology of chronic heart failure is coronary heart disease; 5. Left ventricular ejection fraction <=40%, measured by echocardiogram, NYHA class II to IV; 6. Clinical condition of Coronary heart disease stable at least 1 month before enrollment; 7. Before enrollment, clinical condition of chronic heart failure stable at least 2 weeks, receiving fixed-dose drug therapy and not receiving vein therapy of diuretics,cardiotonics and vasodilators at least 2 weeks; 8. Receiving optimal therapy for chronic ischemic heart failure based guideline.
Exclusion criteria
Exclusion criteria: 1. Participation in other clinical study within the lastest 1 month; 2. Unwilling to stop taking other Chinese medcine for cardiovascular and cerebrovascular disease; 3. Acute myocardial infarction, cerebral stroke, coronary revascularization within 3 months prior to enrollment, or expected to receive coronary revascularization witnin 24 weeks; 4. Received cardiac resynchronization therapy or expected to receive cardiac resynchronization therapy witnin 24 weeks; 5. Left ventricular outflow tract obstruction,myocarditis, giant aneurism ,dissecting aneurysm, congenital cardiac disease and valvular heart disease with hemodynamics disorder; 6. Cardiac shock ,uncontrolled malignant arrhythmia , severe atrioventricular block or sinoatrial block without Implantation of pacemaker; 7. Patients who have poor echocardiographic windows precluding reliable echocardiographic examination during baseline assessment; 8. Uncontrolled hypertension with SBP =180mmHg or DBP=110mmHg; 9. Severe anemia with HGB=9g/dl; 10. Uncontrolled diabetes millitus with fasting blood glucose>11.0mmol/L; 11. Severe hepatic and renal diseases such as active hepatitis ,uremia etc; 12. Abnormal laboratory examination with clinical significance: alanine aminotransferase(ALT)>1.5×ULN, total bilirubin>1.5×ULN, creatinine>2.2mg/dl(194.5µmmol/L),serum potassium5.5mmol/L; 13. A current or prior history within the last 3 years of malignant neoplasm ,except curatively-treated basal cell carcinoma, squamous cell carcinoma; 14. Other severe diseases or psychopathic disorders which clinical conditions may interfere with study, patients whose life expectancy are less than 6 months; 15. Alcholism, drug abuse; history of alchol or drug abuse within last 5 years; 16. Allergy to study drug or placebo; 17. Unable or unwilling to comply with the study protocol; 18. Pregnant or breast feeding women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite endpoints;New York heart function assessmen; | — |
Secondary
| Measure | Time frame |
|---|---|
| Composite endpoints;Changes of symptoms compared with baseline; | — |
Countries
China
Contacts
Public ContactZonggui WU
Outcome results
None listed