A Multi-center, Randomized, Double-blind, Placebo-parallel Controlled Trial for the Efficacy and Safety of Shenfuqiangxin Pills in the Treatment of Chronic Heart Failure(Heart-Kidney Yang Deficiency Syndrome)
- Conditions
- Chronic Heart Failure
- Registration Number
- ITMCTR2000002893
- Lead Sponsor
- Xiyuan Hospital of China Academy of Chinese Medical Sciences, Fuwai Hospital of Chinese Academy of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
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.
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.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method T-proBNP;
- Secondary Outcome Measures
Name Time Method ew York Heart Association classification of cardiac function;6-minute walk test;echocardiography;Minnesota Heart Failure Quality of Life Questionnaire;composite endpoint event;TCM Syndrome Points;