chronic heart failure
Conditions
Interventions
Control Group:Standardized treatment for CHF
Group 1:Standardized treatment for CHF+Danzhu Fuyuan Decoction
Group 3:Standardized treatment for CHF+1/2 dose Danzhu Fuyuan Decoction granules
Group 2:Standardized treatment for CHF+Danzhu Fuyuan Decoction granule
Sponsors
Institute of Basic Theory for Chinese Medicine, China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
All
Age
40 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1) 40-85 years old; 2) Meets the diagnostic criteria for chronic heart failure and has been diagnosed with chronic heart failure for more than 3 months; 3) Heart failure is classified as HFmrEF (EF41-50%) or HFpEF (EF = 50%); 4) The underlying cause of heart failure is coronary heart disease or hypertensive heart disease; 5) NYHA classification stage II-III, with stable clinical symptoms for more than 3 months before enrollment (it is recommended that patients are in the early stage of heart failure and diagnosed 3-6 months ago); 6) The serum NT proBNP content is = 450pg/ml; 7) Patients diagnosed with phlegm stasis syndrome in traditional Chinese medicine clinical practice; 8) Capable of performing echocardiography and 6-minute walk test (6MWT); 9) All other TCM interventions (including Chinese herbal decoction, granule, traditional Chinese patent medicines and simple preparations, acupuncture and moxibustion, etc.) should be stopped for 2 weeks or more; 10) Have received standardized Western medicine treatment at the optimal therapeutic dose for at least 2 weeks; 11)Voluntarily signed the informed consent and having good adherence.
Exclusion criteria
Exclusion criteria: 1) CHF is caused by following condition: valvular disease, congenital heart disease, pericardial disease, cardiac arrhythmia, or other non-cardiogenic factors, including dysfunction of kidney, liver and lung. Acute heart failure or HF after acute myocardial infarction; 2) Patients with worsening heart failure symptoms caused by digitalis poisoning; 3) High risk patients with coronary heart disease; 4) Patients with combined acute coronary syndrome (within 30 days), cardiogenic shock, acute myocarditis, uncontrolled malignant arrhythmia, hypertrophic obstructive cardiomyopathy, constrictive pericarditis, pericardial tamponade, aortic aneurysm, aortic dissection, severe valve disease requiring surgical treatment, and pulmonary embolism; 5) Patients with combined acute and subacute phases of cerebrovascular disease; 6) Individuals who have received implantation of a defibrillator or cardiac resynchronization therapy within 12 weeks, or those who have already undergone cardiac resynchronization therapy; 7) Uncontrolled hypertensive patients with systolic blood pressure = 180/mmHg and/or diastolic blood pressure = 110 mmHg; Systolic blood pressure5.5 mmol/L; 9) Patients with infection, fever, trauma, burn, operation history or active tuberculosis or rheumatic immune disease in the last week; 10) Patients with acute exacerbation of chronic obstructive pulmonary disease or pulmonary heart disease or respiratory failure; 11) Known renal insufficiency, with serum creatinine (Cr) levels>221umol/L in males and>177umol/L in females; 12) Patients with concurrent active liver disease, or accompanied by unexplained sustained elevation of serum transaminases, or with either alanine aminotransferase (ALT) or aspartate aminotransferase (AST) test values greater than twice the upper limit of the normal reference value; 13) Patients with severe primary diseases such as hematopoietic system or malignant tumors, or organ transplant patients; 14) Planned pregnant, pregnant, or lactating women; 15) Patients with severe mental disorders (perceptual disorders, thinking disorders); 16) Individuals with allergic constitution or allergies to two or more types of food or drugs, or allergies to experimental drugs and their raw materials; 17) The researchers believe that there are other situations that are not suitable for participating in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Six minutes walk test; | — |
Secondary
| Measure | Time frame |
|---|---|
| NT-proBNP;Rehospitalization rate and mortality rate within 6 months;Echocardiogram;Classification of NYHA heart function;Minnesota Living with Heart Failure Questionnaire;TCM Syndrome Points; | — |
Countries
China
Contacts
Public ContactWu Meng
Institute of Basic Theory for Chinese Medicine, China Academy of Chinese Medical Sciences
Outcome results
None listed