A Phase 4 interventional study of Qishenyiqi dropping pills and Placebo in Heart Failure, sponsored by Chinese Academy of Medical Sciences, Fuwai Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-22.
Sponsored by Chinese Academy of Medical Sciences, Fuwai Hospital · Phase 4, Interventional, and Treatment
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.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's planned enrollment of 5,380 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Chinese Academy of Medical Sciences, Fuwai Hospital is the lead sponsor of 141 studies on the registry; 48 are open to participants now.
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Exclusion Criteria:
standard treatment + Qishenyiqi dropping pills (QSYQ) (oral use, 1 bag each time, three times a day)
Drug: Qishenyiqi dropping pills
standard treatment + placebo (oral use, 1 bag each time, three times a day).
Drug: Placebo
on the basis of standard treatment, adding QSYQ dropping pills 1 bag each time, 3 times a day
Also known as: QSYQ
on the basis of standard treatment, adding placebo 1 bag each time, 3 times a day
Also known as: Placebo for QSYQ
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.
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
Time to the occurrence of HF death.
Compared with placebo, whether QSYQ prolong the occurrence of HF 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 re-hospitalization for nonfatal myocardial infarction and nonfatal stroke.
Compared with placebo, whether QSYQ prolong the occurrence of total re-hospitalization for nonfatal myocardial infarction and 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
The improvement of Kansas City Cardiomyopathy Questionnaire (KCCQ) score and sub-domain score.
Compared with placebo, whether QSYQ increases KCCQ score and each sub-domain score, to evaluate whether QSYQ has better effectiveness in improving health-related quality of life. Values for the domains range from 0 to 100 with higher scores indicating lower symptom burden and better quality of life. Subdomains include physical limitation, symptoms, quality of life, social limitation, symptom stability, and self-efficacy-the first 4 are combined into an overall summary scale.
Time frame: up to 30 months
Level of NT-proBNP in patients with HFrEF
Compared with placebo, whether QSYQ decrease the NT-proBNP level in patients with HFrEF at the 24th week and the 48th week.
Time frame: from baseline to week 24 and week 48
Value of LVEF in patients with HFrEF
Compared with placebo, whether QSYQ improve the LVEF in patients with HFrEF at the 48th week.
Time frame: from baseline to week 48
Level of BNP in patients with HFrEF.
Compared with placebo, whether QSYQ decreases the level of BNP in patients with HFrEF at the 48th week.
Time frame: from baseline to week 48
Value of clinical comprehensive score in patients with HFrEF.
Compared with placebo, whether QSYQ improves the clinical comprehensive score in patients with HFrEF at the 48th week. Clinical comprehensive score is a 7-scale from the best improvement to the worst deterioration assessed by researchers according to the three components: change of NYHA class level, patients' global self-assessment (assessed by patients themselves according to a 7-scale, from the best improvement to the worst deterioration) and occurence of major adverse event (defined as cardiovascular mortality and heart failure hospitalization).
Time frame: from baseline to week 48
Effectiveness in reducing medical cost and increasing Quality-adjusted life year （QALYs）in patients with HFrEF.
Compared with placebo, whether QSYQ reduces the medical cost and increases the QALYs in patients with HFrEF at the end of treatment, to evaluate the pharmacoeconomic effect.
Time frame: up to 30 months
This study is status unknown, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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Chinese Academy of Medical Sciences, Fuwai Hospital