Chronic Heart Failur
Conditions
Interventions
experimental group:Neucardin, 10 hours per day i.v drip for the first 10 days (0.6ug/ kg/day), followed by weekly 10 minutes i.v bolus (0.8ug/kg/day), from the 3rd week for 23 weeks
control group:Placebo, 10 hours per day i.v drip for the first 10 days (0ug/kg/ day), followed by weekly 10 minutes i.v bolus (0ug/kg/ day), from the 3rd week for 23 weeks
Sponsors
Fuwai Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 75 years, gender balance (no more than 960 subjects of either gender in total 1600 subjects). 2. Left ventricular ejection fraction (LVEF)<= 40% (ECHO). 3. Subjects with chronic heart failure (NYHA class II OR III ). 4. 600 pg/ml <= NT-proBNP <= 1700 pg/ml ( by Roche assay Kit in central lab). 5. Diagnosed as chronic systolic heart failure (history, symptoms, signs), and in stable condition in the last one month. 6. Receiving standard therapy for chronic heart failure, reach target dose or max tolerable dose for one month, or has not changed the dose for one month before randomization. 7. Capable of signing the informed consent form.
Exclusion criteria
Exclusion criteria: 1. New chronic heart failure patients, or patients receiving standard therapy on chronic heart failure for less than 3 months. 2. Patients with hypertrophic cardiomyopathy, rheumatic heart disease, constrictive pericarditis, significant valvular pathological change or congenital heart diseases, primary or secondary severe pulmonary artery hypertension. 3. Ischemic heart failure without recanalization or with recanalization in recent six months. 4. Acute MI in the last 3 months. 5. Unstable angina. 6. Patients with acute pulmonary edema or acute hemodynamic disorder. 7. Patients with right heart failure caused by pulmonary disease. 8. Patients diagnosed with pericardial effusion (> 50 ml) or pleural effusion(>200 ml), or evidenced by Echocardiogram. 9. Cardiac surgery or cerebrovascular accident within recent six months. 10. Preparing for heart transplantation or CRT, or has received CRT. 11. Serious ventricular arrhythmia (sustained ventricular tachycardia or frequent paroxysmal ventricular tachycardia). 12. Diagnosis of perinatal or chemotherapy-induced cardiomyopathy in last12 months. 13. Serious hepatic or renal dysfunction (bilirubin 1.5 times above the normal upper limit, AST or ALT 2 times above the normal upper limit, serum creatinine#2.0mg/dL, HBV or HCV positive). 14. Serum potassium 5.5 mmol/L. 15. Systolic blood pressure 160mmHg. 16. Women of childbearing age who have a pregnancy plan within 2 years (women of childbearing age are defined as women who have a pregnancy physiology). 17. Pregnant or lactating women. 18. Patients who participated in any clinical trial in the recent three months. 19. Subject with a life expectancy less than 6 months as assessed by the investigator. 20. Serious nervous system diseases (Alzheimer's disease, advanced Parkinsonism),lower limb defects, or deaf-mute. 21. History of any malignancy or suffering from cancer, or biopsy proven pre-malignant condition (e.g., DICS or cervical atypia). 22. Evidence (physical examination, chest X-ray (CXR), ECHO or other tests) shows some active malignancy or adenoidal hypertrophy or neoplasm that has an effect on heart function or the endocrine system, e.g., pheochromocytoma or hyperthyroidism (Thyroid nodules with normal thyroid function do not need to be excluded). 23. As judged by the investigator that the subject cannot complete the study or adhere to the study requirements (due to the management reasons or others).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 52-weeks all-cause mortality; | — |
Secondary
| Measure | Time frame |
|---|---|
| 52-weeks mortality caused by cardiovascular events;52-weeks all-cause mortality of female subjects;52-weeks all-cause mortality of male subjects;Percentage of all-cause re-hospitalization;Percentage of Participants with re-hospitalization caused by worsening heart failure;Change of NT-proBNP level at the 25th week and 52th week;New York Heart Association (NYHA) functional classification; | — |
Countries
China
Contacts
Public ContactRunlin Gao
Fuwai Hospital
Outcome results
None listed