chronic heart failure
Conditions
Interventions
rhNRG-1:Standard Therapy Based Trail plus rhNRG-1
placebo:Standard Therapy Based Trail plus placebo
Sponsors
Chinese Academy of Medical Sciences, Fuwai Heart Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18-80 years old, no limitation in gender; 2. Left ventricular ejection fraction (LVEF) <=40% (ECHO); 3. Patients with chronic heart failure (NYHA class III or IV); 4. Relatively stable clinical condition (without fluid retention and the body weight was stable) one week prior to beginning of study; 5. Subject understands and signed the Informed Consent form.
Exclusion criteria
Exclusion criteria: 1. Acute pulmonary edema or acute hemodynamic disorder; 2. Right heart failure due to pulmonary disorders; 3. Acute myocardial infarction within the previous 3 months; 4. Constrictive pericarditis, significant valve disease, congenital heart disease, severe pulmonary hypertension; 5. Unstable angina; 6. Subject underwent cardiac surgery or cerebrovascular events within the previous six months; 7. Subjects who plan to have cardiac transplantation; 8. Mobitz Type II or III atrial ventricular block, severe ventricular arrhythmia (polymorphic and frequent premature ventricular beats or frequent non-sustained ventricular tachycardia); 9. Severe hepatic and renal insufficiency (serum creatinine>3mg/dl, AST or ALT is ten times higher than the upper limit of normal range); 10. Serum potassium5.5mmol/L; 11. Systolic blood pressure 160mmHg; 12. Women of childbearing potential not on contraceptives or female subject is pregnant or plans to become pregnant; 13. Subject participated in any other clinical trial within the previous three months; 14. Subject with severe neurological disorders (Alzheimer disease, progressive stage of Parkinson's syndrome) ; 15. Subject with previous history of tumor, or current history of tumor, or subject with pre-cancerous disease manifested by pathological examination (such as ductal carcinoma in situ of the breast or cervical epithelial dysplasia); 16. Examinations (physical examination, X-ray examination, type-B ultrasonic detection or other methods) reveal that the subject has malignant mass, glandular hyperplasia or adenoma with endocrine activity, or impact on heart function, or abnormal endocrine function (such as pheochromocytoma, thyroid enlargement); 17. The Investigator deems for whatever reason that the subject is not likely to complete the study or comply with the study procedures or any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hospitalization rate and mortality; | — |
Secondary
| Measure | Time frame |
|---|---|
| Cardiac function (two dimensional echocardiography), NYHA heart function class, 6-minute walking test; | — |
Countries
China
Contacts
Public ContactAcademician Runlin Gao
Outcome results
None listed