Efficacy and Safety of QiShen YiQi Dripping Pills in Chronic Heart Failure

Inclusion Criteria:

• Conformed to the diagnostic criteria of CHD and chronic heart failure

• Conformed to the TCM syndrome differentiation standard of chronic heart failuresyndrome of Qi deficiency and blood stasis

• Male or female subjects aged ≥ 40 years and ≤80 years

• LVEF<45%(modified Simpson method)

• NYHAⅡ-Ⅲ

• Received standardized drug therapy for chronic heart failure at least 2 weeks beforerandomization, and did not receive intravenous therapy (vasoactive drugs, diuretics)within 2 weeks without adjustment of dose

• Ability to understand the requirements of the study and willingness to providewritten informed consent

• Have no pregnancy program and take effective contraceptive measures voluntarily

• Abide by the experimental protocol and cooperate with the data collection accordingto the researcher's judgment

Exclusion Criteria:

• Patients with heart failure caused by other heart diseases,such as cor pulmonale,congenital heart disease, primary pulmonary hypertension, secondary severe pulmonaryhypertension, severe stenosis or insufficiency of heart valves, cardiomyopathy (including hypertrophic cardiomyopathy, restrictive cardiomyopathy, dilatedcardiomyopathy, alcoholic cardiomyopathy), moderate massive pericardial effusion,constrictive pericarditis, infective endocarditis

• Heart failure caused by systemic diseases or other systemic diseases, such asrheumatic immune and secretory diseases;heart failure caused by kidney disease, lungdisease, liver disease and serious infection;heart failure caused by chemical ortoxicological causes

• Patients who had acute myocardial infarction, underwent coronary revascularizationor left ventricular remodeling, underwent cardiac resynchronization with pacemakerimplantation, underwent cardiothoracic surgery within 3 months prior to receivingthe experimental drug, patients with other acute coronary syndrome, pulmonaryembolism or acute cerebrovascular disease

• Severe arrhythmias such as ventricular tachycardia, second degree Ⅱ type or abovesinus atrial or atrioventricular block without pacemaker treatment, average QTc > 500ms, heart rate < 50 beats/min, etc

• Complicated with other serious diseases, such as pheochromocytoma, hematologicdiseases, organ transplantation patients, and any history of malignant tumor

• The presence of uncontrolled hypertension, systolic blood pressure ≥160mmHg and/ordiastolic blood pressure ≥100mmHg

• Hypotension with a systolic blood pressure <80mmHg and/or a diastolic blood pressure <50mmHg

• Patients with hepatic and/or renal dysfunction (ALT≥ 2 times the upper limit ofnormal, and/or estimated glomerular filtration rate (EGFR) <30 mL /min/1.73m2

• HbA1c ≥9.0%, or fasting blood glucose ≥13.9mmol/L

• Moderate and severe anemia (Hb < 90g/L)

• Serum potassium ≥5.5mmol/L

• Patients requiring anticoagulants who did not achieve dose stabilization for 1 monthor INR > 3.0

• In patients who need to take antiplatelet drugs, the dose was stable for less than 1month, and the platelet value was lower than the lower limit of normal value

• Allergic to the test drug or its related taste or ingredients

• People with complicated mental illness, poor condition control and drug addiction

• Unable to complete 6MWT

• Pregnant or lactating women

• Participation in other studies and use of investigational drugs from other studieswithin 3 months prior to screening

• The investigator deems that the patient is not suitable to participate in the study,including the investigator's judgment that the patient is unable to complete thestudy or comply with the requirements of the study