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

Korábbi kezelés

• Patients who had acute myocardial infarction, underwent coronary revascularization or left ventricular remodeling, underwent cardiac resynchronization with pacemaker implantation, underwent cardiothoracic surgery within 3 months prior to receiving the experimental drug, patients with other acute coronary syndrome, pulmonary embolism or acute cerebrovascular disease
• Participation in other studies and use of investigational drugs from other studies within 3 months prior to screening

Más betegség

• Patients with heart failure caused by other heart diseases,such as cor pulmonale, congenital heart disease, primary pulmonary hypertension, secondary severe pulmonary hypertension, severe stenosis or insufficiency of heart valves, cardiomyopathy (including hypertrophic cardiomyopathy, restrictive cardiomyopathy, dilated cardiomyopathy, alcoholic cardiomyopathy), moderate massive pericardial effusion, constrictive pericarditis, infective endocarditis
• Heart failure caused by systemic diseases or other systemic diseases, such as rheumatic immune and secretory diseases;heart failure caused by kidney disease, lung disease, liver disease and serious infection;heart failure caused by chemical or toxicological causes
• Complicated with other serious diseases, such as pheochromocytoma, hematologic diseases, organ transplantation patients, and any history of malignant tumor
• The presence of uncontrolled hypertension, systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg
• Allergic to the test drug or its related taste or ingredients
• People with complicated mental illness, poor condition control and drug addiction

Laborértékek

• Severe arrhythmias such as ventricular tachycardia, second degree Ⅱ type or above sinus atrial or atrioventricular block without pacemaker treatment, average QTc > 500ms, heart rate < 50 beats/min, etc
• Patients with hepatic and/or renal dysfunction (ALT≥ 2 times the upper limit of normal, and/or estimated glomerular filtration rate (EGFR) <30 mL /min/1.73m2
• HbA1c ≥9.0%, or fasting blood glucose ≥13.9mmol/L
• Serum potassium ≥5.5mmol/L
• Patients requiring anticoagulants who did not achieve dose stabilization for 1 month or INR > 3.0
• In patients who need to take antiplatelet drugs, the dose was stable for less than 1 month, and the platelet value was lower than the lower limit of normal value

Egyéb

• Hypotension with a systolic blood pressure <80mmHg and/or a diastolic blood pressure <50mmHg
• Moderate and severe anemia (Hb < 90g/L)
• Unable to complete 6MWT
• Pregnant or lactating women
• 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 the study or comply with the requirements of the study

• Conformed to the diagnostic criteria of CHD and chronic heart failure
• Conformed to the TCM syndrome differentiation standard of chronic heart failure syndrome 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 before randomization, 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 provide written informed consent
• Have no pregnancy program and take effective contraceptive measures voluntarily
• Abide by the experimental protocol and cooperate with the data collection according to the researcher's judgment