This is a multicenter, randomized, double-blind, placebo-controlled study including patients with ejection fraction decreased heart failure under standardized treatment, to evaluate QiShenYiQi (QSYQ) dropping pill's curative effect in reducing cardiovascular death and heart failure rehospitalization compared with placebo.
This is a prospective, large-scale samples, randomized, double-blind, placebo parallel-controlled, multicenter study to evaluate QSYQ's curative effect in reducing cardiovascular death and heart failure rehospitalization in patients with ejection fraction decreased heart failure(LVEF≤40%)under standardized treatment. The results will provide clinical evidence for combined treatment of traditional Chinese medicine and western medicine in ejection fraction decreased heart failure. There are two treatment groups in the study, which are the treatment group with standard treatment + QSYS (oral use, 1 bag each time, three times a day) , and the control group with standard treatment + placebo (oral use, 1 bag each time, three times a day) . The subjects are patients with ejection fraction decreased (≤40%) heart failure (NYHA II-IV). The sample size is 5380. For the primary end event, type I error is bilateral 0.05, and POWER was 0.8. The CV death and the HF readmission rate in the trial control group is 15%, and 12.7% in the experimental group. The trial cycle is about 3 years. A total of 4373 subjects will be assigned to the experimental group and the control group at a proportion of 1:1. The primary endpoint was expected to be 1211 cases. Taking into account the annual rate of lost to follow-up is about 18%, the final sample cases is 5380. During the treatment period and extends to at most 2weeks after treatment, patients will get examination including interviews (direct inquiries about the occurrence of adverse events and the situation of taking drugs), physical examination, body weight and the ECG. Laboratory parameters to evaluate clinical safety, such as routine blood, serum creatinine and urea nitrogen, electrolyte (serum potassium, sodium and chloride) and liver enzymes will be taken regularly. Researchers need to record and evaluate any occurrence of adverse events (AE) or serious adverse event (SAE) and its relevance to study medicine. The primary endpoint is to evaluate whether QSYQ can reduce cardiovascular death and heart failure rehospitalization in chronic heart failure patients with reduced ejection infarction (HFREF) compared with placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
5,380
on the basis of standard treatment, adding QSYQ dropping pills 1 bag each time, 3 times a day
on the basis of standard treatment, adding placebo 1 bag each time, 3 times a day
Fuwai Hospital
Beijing, Beijing Municipality, China
Time to the occurrence of cardiovascular (CV) death or heart failure (HF) re-hospitalization.
Compared with placebo, whether QSYQ prolong the occurrence of CV death or HF re-hospitalization of patients with chronic heart failure with lower ejection fraction (HFrEF). The treatment arm with the delayed events happening will be deemed as having a successful response.
Time frame: up to 30 months
Time to the occurrence of all-cause death.
Compared with placebo, whether QSYQ prolong the occurrence of all-cause death of patients with HFrEF. The treatment arm with the delayed events happening will be deemed as having a successful response.
Time frame: up to 30 months
Time to the occurrence of all-cause death or HF re-hospitalization.
Compared with placebo, whether QSYQ prolong the occurrence of all-cause death or HF re-hospitalization of patients with HFrEF. The treatment arm with the delayed events happening will be deemed as having a successful response.
Time frame: up to 30 months
Time to the occurrence of CV death.
Compared with placebo, whether QSYQ prolong the occurrence of CV death of patients with HFrEF. The treatment arm with the delayed events happening will be deemed as having a successful response.
Time frame: up to 30 months
Time to the occurrence of total HF re-hospitalization.
Compared with placebo, whether QSYQ prolong the occurrence of total HF re-hospitalization of patients with HFrEF. The treatment arm with the delayed events happening will be deemed as having a successful response.
Time frame: up to 30 months
Time to the occurrence of composite endpoint.
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Compared with placebo, whether QSYQ prolong the occurrence of composite endpoint (CV death, hospitalization for deteriorating heart failure, hospitalization for nonfatal myocardial infarction, and hospitalization for nonfatal stroke) of patients with HFrEF. The treatment arm with the delayed events happening will be deemed as having a successful response.
Time frame: up to 30 months
Time to the first occurrence of HF hospitalization.
Compared with placebo, whether QSYQ prolong the first occurrence of HF hospitalization of patients with HFrEF. The treatment arm with the delayed events happening will be deemed as having a successful response.
Time frame: up to 30 months
Change from baseline to week 48 for the Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score.
Compared with placebo, whether QSYQ improve the KCCQ score of patients with HFrEF at the 48th week. KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. KCCQ clinical summary score is a composite assessment of physical limitations and total symptom scores. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Time frame: from baseline to week 48
Change from baseline to week 48 for the 6 minutes walking distance.
Compared with placebo, whether QSYQ improve the 6 minutes walking distance of patients with HFrEF at the 48th week.
Time frame: from baseline to week 48