About this trial
This trial will evaluate the efficacy and safety of Qishen Yiqi Dripping Pills in treatment of Chronic Heart Failure with reduced ejection fraction resorted from Coronary Heart Disease (Syndrome of Qi Deficiency with Blood Stasis).
Eligibility criteria
Qualifiers
Male or female subjects aged ≥ 18 years and ≤80 years when signing the informed consent form.
Conformed to the diagnostic criteria of coronary heart disease and chronic heart failure.
Conformed to the TCM syndrome differentiation standard of chronic heart failure syndrome of Qi deficiency and blood stasis.
NYHA Functional Classification Ⅱ-Ⅲ.
Disqualifiers
Heart failure caused by other cardiovascular diseases, such as infectious endocarditis, cardiac amyloidosis, genetic abnormalities (genetic factors related to hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy), valve and cardiac structure abnormalities (moderate or above aortic valve stenosis, other severely narrowed or incompetent heart valves, congenital heart disease), constrictive pericarditis, moderate or large pericardial effusion.
Heart failure caused by other non-cardiovascular diseases, such as severe infection, autoimmune diseases, tumor metastasis or infiltration, pulmonary heart disease, primary pulmonary hypertension, secondary severe pulmonary hypertension, kidney diseases, liver diseases, cardiac toxic injury (cardiotoxic drugs such as anti-tumor drugs, alcoholic cardiomyopathy).
Within 3 months before receiving the investigational drug, had acute myocardial infarction, undergone revascularization [percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG)] treatment, undergone left ventricular assist device [cardiac resynchronization therapy (CRT), implantable cardioverter defibrillator (ICD), etc.] treatment, undergone cardiac surgery (left ventricular reconstruction, heart transplantation, etc.) treatment, had acute cerebrovascular events (acute ischemic stroke, cerebral hemorrhage, transient ischemic attack).
Planned to undergo revascularization (PCI, CABG, etc.) or left ventricular assist device (CRT, ICD, etc.) treatment, or other cardiac surgery during the trial.
Trial design
Treatments tested in this trial
- Qishen Yiqi Dripping Pills 2 bags
- Qishen Yiqi Dripping Pills placebo 2 bags