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

Tasly Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Chronic Heart Failure With Reduced Ejection Fraction

Treatments: Drug: QiShen YiQi Dripping Pills placebo 3 bags; Drug: Low dose QiShen YiQi Dripping Pills 3 bags; Drug: High dose QiShen YiQi Dripping Pills 3 bags

Study type: Interventional

Funder types: Industry

Identifiers

NCT04983043

TSL-TCM-QSYQDW-HFrEF-Ⅱ

Details and patient eligibility

About

This study will evaluate the efficacy and safety and the best effective dose of QiShen YiQi Dripping Pills in the treatment of chronic heart failure with decreased ejection fraction of CHD (Qi deficiency and blood stasis syndrome).

Full description

QiShen YiQi Dripping Pills are oral, compound traditional chinese medicine prepatations. This study will evaluate the efficacy and safety and the best effective dose of QiShen YiQi Dripping Pills in the treatment of chronic heart failure with decreased ejection fraction of CHD (Qi deficiency and blood stasis syndrome).

Enrollment: 228 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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
• 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
• 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
• 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
• 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 of normal, 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 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
• 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 studies within 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 the study or comply with the requirements of the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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228 participants in 3 patient groups, including a placebo group

Low dose group

Experimental group

Description:

Low dose QiShen YiQi Dripping Pills, 3 bags, take orally after meals, 3 times a day

Treatment:

Drug: Low dose QiShen YiQi Dripping Pills 3 bags

High dose group

Experimental group

Description:

High dose QiShen YiQi Dripping Pills, 3 bags, take orally after meals, 3 times a day

Treatment:

Drug: High dose QiShen YiQi Dripping Pills 3 bags

Placebo group

Placebo Comparator group

Description:

QiShen YiQi Dripping Pills placebo, 3 bags, take orally after meals, 3 times a day

Treatment:

Drug: QiShen YiQi Dripping Pills placebo 3 bags