chronic systolic heart failure
Conditions
Interventions
Group rhNRG-:rhNRG-1 0.6ug/kg/day for IV infusion (10 hours)for 10consecutive days, then 0.8ug/kg one per week for IV injiection (10 minutes) for 23 weeks
Group placebo:placebo 0.6ug/kg/day for IV infusion (10 hours)for 10consecutive days, then 0.8ug/kg one per week for IV injiection (10 minutes) for 23 weeks
Sponsors
Cardiovascular Institute & Fuwai Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 80, both sex; 2. Left ventricular ejection fraction (LVEF)<=40% (ECHO); 3. NYNA functional class III~IV; 4. Clinical symptom is steadily in the latest 1 week (no fluid retension, no weight gain); 5. Capable of signing the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with acute pulmonary edema or acute hemodynamic disorder; 2. Patients with right heart failure caused by pulmonary disease; 3. Patients diagnosed with pericardial effusion or pleural effusion; 4. Patients with myocardial infarction during the preceding 3 months; 5.Patients with constrictive pericarditis, significant valvular pathological change or congenital heart diseases, severe pulmonary artery hypertension; 6.Unstable angina pectoris; 7.Cardiac surgery or cerebrovascular accident within recent six months; 8.Preparing for heart transplantation; 9.Serious ventricular arrhythmia (multi-morphological premature ventricular contraction, frequent paroxysmal ventricular tachycardia); 10.Serious hepatic or renal dysfunction caused by organic pathological changes (Cr>3.0mg/dl, AST or ALT 10 times above the normal upper limit); 11.Serum potassium 5.5 mmol/L; 12.Systolic blood pressure 160mmHg; 13.Pregnant or plan to pregnant; 14.Patients who participated in any clinical trial in the recent three months; 15. Subject with a life expectancy less than 3 months as assessed by the investigator; 16.Serious nervous system diseases (Alzheimer's disease, advanced Parkinsonism); 17.History of any malignancy or suffering from cancer, or biopsy proven; pre- malignant condition (eg DICS or cervical atypia); 18.Evidence (physical examination, CXR, ECHO or other tests) shows some active malignancy or adenoidal hypertrophy or neoplasm has effect on heart function or endocrine system, eg pheochromocytoma or hyperthyroidism; 19.Judging by the investigator, the patients could not complete the study or adhere to the study requirements (due to the management reasons or others).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| all cause death; | — |
Secondary
| Measure | Time frame |
|---|---|
| NT-proBNP;cardiac function (ECHO, QOL, NHHA, 6MW);rehospitalization rate; | — |
Countries
China
Contacts
Public ContactRunlin Gao
Outcome results
None listed