chronic heart failure
Conditions
Interventions
middle dose:Standard Therapy Based Phase II Clinical Study plus middle dose rhNRG-1
placebo:Standard Therapy Based Phase II Clinical Study plus placebo
Low dose:Standard Therapy Based Phase II Clinical Study plus low dose rhNRG-1
Sponsors
Chinese Academy of Medical Sciences, Fuwai Heart Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Men or women aged between 18-65 years; 2. Subject with left ventricular ejection fraction (LVEF) ? 40% (by two dimensional echocardiography); 3. Subject with cardiac function grade NYHA class II or III; 4. Subject with definitely diagnosed chronic systolic heart failure (including medical history, clinical symptoms and signs) with stable clinical symptoms within last 1 month; 5. Subject accepting standard treatment of chronic heart failure at the target dose or maximum tolerance dose for over 1 month, or unchanged dose within last 1 month; 6. The subject understand and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients suffering from any of the following disease: acute myocardial infarction, cardiac ischemia indicated by 6-minute walk test, hypertrophic cardiomyopathy, constrictive pericarditis, significant valve disease or congenital heart disease, severe pulmonary hypertension; 2. Subject suffering from ischemic heart failure without the revascularization or undergone the revascularization within last 6 months; 3.Subject has undergone cardiac surgery or cerebrovascular events within last 6 months; 4. Subject plan to accept heart transplantation; 5. Subject suffering from severe hepatic and renal insufficiency caused by organic disease (serum creatinine >2.0mg/dl, AST or ALT over 5 times of upper normal limit); 6. Subject needs mechanical ventilation; 7. Subject with systolic blood pressure 160mmHg; 8.Subject with chronic heart failure complicated with acute hemodynamic disturbance or acute decompensation; 9. Subject with any type of the following arrhythmia: Mobitz Type II or III° atrioventricular block, severe ventricular arrhythmia (multifocal frequent premature ventricular beats, frequent non-sustained ventricular tachyrhythmia); 10. Subject with cardiac pacemaker or defibrillator and accepting cardiac resynchronization therapy (CRT); 11. Subject with serum potassium 5.5 mmol/L; 12. Pregnant or plan to become pregnant; 13.Childbearing-aged female subjects who were unmarried or do not bear child; 14. Subject with life expectancy less than 6 months as assessed by investigators; 15. Subject participated in any other clinical study within last 3 months; 16. Subject with tumor history or suffering from tumor, or precancerous lesions (including breast ductal carcinoma in situ, cervical atypical hyperplasia, etc) by pathological examination; 17. Examinations (physical examination, X-ray examination, type-B ultrasonic detection or other methods) reveal that the subject has malignant mass, gland hyperplasia or adenoma with endocrine activity, or impact on heart, or endocrine function (such as pheochromocytoma, thyroid enlargement); 18. Subject who investigator deems for unlikely to complete the study or comply with the study procedures (due to administration or any other reason).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6-minute walk test; | — |
Secondary
| Measure | Time frame |
|---|---|
| Cardiac function classification (NYHA), quality of life; | — |
Countries
China
Contacts
Public ContactAcademician Runlin Gao
Outcome results
None listed