Chronic Heart Failure
Conditions
Interventions
Control group:placebo
Sponsors
Xiyuan Hospital of China Academy of Chinese Medical Sciences, Fuwai Hospital of Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Meet the diagnostic criteria of chronic heart failure, and have a history of chronic heart failure for more than 3 months or clinical symptoms of heart failure for more than 3 months; 2. Chronic heart failure patients with heart-kidney yang deficiency syndrome based on syndrome differentiation of TCM; 3. Aged 18-80 years; 4. Echocardiography showed the left ventricular ejection fraction (LVEF) was < 40%; 5. The patients with II to IV degree of the cardiac function stardand of New York Heart Association; 6. Serum N-terminal proBNP content =450pg/ml; 7. Those who received at least 2 weeks of standardized western medicine treatment with the optimal therapeutic dose; 8. Those who had not used traditional Chinese medicine for heart failure within 2 weeks before enrollment; 9. Those who participate in this clinical trial voluntarily, understand and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Those who undergo coronary revascularization and cardiac resynchronization therapy within 12 weeks or cardiac resynchronization therapy planned within 12 weeks; 2. Those who are combined with severe primary diseases such as liver and kidney hematopoiesis, alanine transaminase, aspartate transaminase, alkaline phosphatase and serum creatinine were 2 times higher than the upper limit of normal value; serum potassium was more than 5.5 mmol/L;patients with tumor, severe neuroendocrine disease and mental illness; 3. Patients with left ventricular outflow tract obstruction, acute myocarditis, hypertrophic cardiomyopathy, restricted cardiomyopathy, aortic aneurysm, arterial dissection, congenital heart disease, severe arrhythmia, and significant hemodynamic changes in unrepaired heart valve disease; 4. Patients with uncontrolled hypertension,systolic blood pressure =180mmHg and/or diastolic blood pressure >=100mmHg; 5. Patients with severe peripheral arterial disease, acute attack of chronic obstructive pulmonary disease, pulmonary vascular disease such as primary pulmonary hypertension or pulmonary hypertension due to autoimmune disease; 6. Women who are pregnant or preparing for pregnancy and lactation; 7. Persons with allergies or known to be allergic to therapeutic drugs; 8. Participants in clinical studies of other drugs within 1 month.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| NT-proBNP; | — |
Secondary
| Measure | Time frame |
|---|---|
| echocardiography;composite endpoint event;New York Heart Association classification of cardiac function;6-minute walk test;Minnesota Heart Failure Quality of Life Questionnaire;TCM Syndrome Points; | — |
Countries
China
Contacts
Public ContactMa Xiaochang
Outcome results
None listed