chronic heart failure
Conditions
Interventions
mid dose:Standard Therapy Based Trial plus middle dose recombinant human Neuregulin-1
Sponsors
Chinese Academy of Medical Sciences, Fuwai Heart Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Men or women aged between 18-80 years; 2. Subject with left ventricular ejection fraction (LVEF) >=50% (by two dimensional echocardiography); 3. Subject with cardiac function grade NYHA class II or III; 4. Subject with definitely diagnosed chronic heart failure (including 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. Subjects that suffered from any of the following diseases: acute myocardial infarction, cardiac ischemia indicated by 6-minute walk test, constrictive pericarditis, significant valve disease or congenital heart disease, severe pulmonary hypertension; 2. Subject that suffered from ischemic heart failure without revascularization or had undergone revascularization within the last 6 months; 3.Subject who suffered from malignant hypertension or hypertensive crisis; 4. Subject with a blood pressure >160/90mmHg, or received intravenous antihypertensive medication within the last 1 month; 5. Subject who suffered from severe aortosclerosis; 6. Subject who suffered from aortic or mitral regurgitation; 7. Subject who had undergone cardiac surgery or had cerebrovascular events within the last 6 months; 8.Subject who suffered 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); 9. Subject who needed mechanical ventilation; 10. Subject with chronic heart failure complicated with acute hemodynamic disturbance or acute decompensation; 11. Subject with any type of the following arrhythmias: Mobitz Type II or III atrial ventricular block, severe ventricular arrhythmia (multifocal frequent ventricular topic beat, frequent ventricular tachyrhythmia); 12. Subject with serum potassium levels 5.5 mmol/L; 13.Subject who had a cardiac pacemaker or defibrillator and was accepting cardiac resynchronization therapy (CRT); 14. A subject who was pregnant or planned to become pregnant; 15. A childbearing-aged female subject who was unmarried or did not bear children 16. Subject with a life expectancy that was less than 6 months as assessed by investigators; 17. Subject who participated in any other clinical trial within the last 3 months; 18. Subject with a history of tumors or was suffering from tumors, or precancerous lesions (including breast ductal carcinoma in situ, cervical atypical hyperplasia, etc) by pathological examination; 19. Subject who had malignant masses, gland hyperplasia and adenoma which showed endocrine activities or could influence cardiac or endocrine function (including pheochromocytoma, pheochromocytoma, etc), by physical examination X-ray examination and b-ultrasound examination, etc; 20. Subject, which the investigator deemed unlikely to complete the study or comply with the study procedures (due to administration or any other reason).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Systolic and diastolic function improvement of left ventricle, the main index include Ea, E, A, E/A, lung blood flow, LVEF, EDV, ESV, CO; | — |
Secondary
| Measure | Time frame |
|---|---|
| Cardiac function classification (NYHA), 6-minute walk test, quality of life; | — |
Countries
China
Contacts
Public ContactAcademician Runlin Gao
Outcome results
None listed