Efficacy and Safety of Qishenyiqi Dripping Pills for Treating Chronic Heart Failure With Reduced Ejection Fraction (Syndrome of Qi Deficiency and Blood Stasis) Due to Coronary Heart Disease

  • STATUS
    Recruiting
  • End date
    Dec 1, 2023
  • participants needed
    228
  • sponsor
    Tasly Pharmaceutical Group Co., Ltd
Updated on 27 May 2022

Summary

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

Details
Condition Chronic Heart Failure With Reduced Ejection Fraction
Treatment Low dose Qishenyiqi Dripping Pills 3 bags, High dose Qishenyiqi Dripping Pills 3 bags, Qishenyiqi Dripping Pills placebo 3 bags
Clinical Study IdentifierNCT04983043
SponsorTasly Pharmaceutical Group Co., Ltd
Last Modified on27 May 2022

Eligibility

Yes No Not Sure

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 ≤75 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
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