Chronic heart failure
Conditions
Interventions
Qiwei Fangji Huangqi Granules :On the basis of conventional treatment, Qiwei Fangji Huangqi granules were given
Conventional therapy :Conventional treatment (refer to the Chinese Guidelines for the Diagnosis and Treatment of Heart Failure 2018)
Sponsors
Hangzhou Traditional Chinese Medicine Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. The diagnosis of western medicine referred to the "Chinese Guidelines for the Diagnosis and Treatment of Heart Failure 2018" issued by the Chinese Society of Cardiology in 2018, which met the diagnostic criteria of chronic heart failure, and HFmrEF and HFpEF patients; 2. TCM diagnosis conforms to the syndrome differentiation criteria of TCM chronic heart failure with qi deficiency and blood stasis combined with internal water and drink cessation; 3. NYHA class II-III; 4. Age between 18 and 80 years old, both male and female; 5. Voluntarily accept the drug treatment and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Poorly controlled hypertension, defined as a resting systolic blood pressure of 180mmHg or higher or a diastolic blood pressure of 110mmHg or higher on two independent visits before randomization; (2) patients with acute coronary syndrome, patients with revascularization within one month or patients with planned revascularization within one week, patients with cardiogenic shock, fatal arrhythmia, myocarditis, constrictive pericarditis, pulmonary embolism, etc. 3. Autoimmune diseases such as systemic lupus erythematosus, giant-cell myocarditis; 4. Patients with serious diseases (such as malignant tumors) or mental disorders that affect their survival and whose condition is poorly controlled or drug users have not been abstinent; 5. Severe hepatic and renal dysfunction (alanine aminotransferase (ALT) =3 times the upper limit of normal, creatinine (Cr) =3mg/dL); 6. Patients with known allergy to the study drug (including its prescription ingredients); 7. Those who plan to be pregnant or are pregnant or lactating, or who cannot be guaranteed effective contraception during the trial period; 8. Patients enrolled in other clinical trials within the past 3 months; 9. Patients with ineligible factors were identified by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6 minutes walk distance; | — |
Secondary
| Measure | Time frame |
|---|---|
| 3, 6 months of major adverse cardiovascular events (MACE) events (including cardiovascular death, non-fatal myocardial infarction (new onset myocardial infarction));Rehospitalization for heart failure;NYHA Classification;TCM syndrome scoring scale;Quality of Life Scale (Kansas City Cardiomyopathy Quality of Life Scale (KCCQ));N-terminal B natriuretic peptide precursor;The average intake and output of 24 hours during hospitalization;Diuretic use;Left ventricular end-diastolic Diameter (LVEDD);Left ventricular ejection fraction (LVEF);Interventricular septal thickness (IVSd);Left ventricular posterior wall Thickness (LVPWd);Lee's heart failure scale;Total cholesterol (TC);Triglyceride (TG);high density lipoprotein cholesterol (HDL-C);low density lipoprotein cholesterin (LDL-C);Apolipoprotein A1;Apolipoprotein B;homocysteine (Hcy);lactic dehydrogenase (LDH);creatine kinase (CK); Creatine Kinase Isoenzyme (CK-MB);C-reactive protein (CRP);Interleukin-6 (IL-6);Other biochemical indices; | — |
Countries
China
Contacts
Public ContactChen Tielong
Hangzhou Traditional Chinese Medicine Hospital
Outcome results
None listed