NCT04983043已完成2 期
A Multi-center, Randomized, Double-blind, Placebo-parallel Controlled, Standardise-loaded Ⅱ Clinical Trial of Efficacy and Safety of QiShen YiQi Dripping Pills in Chronic Heart Failure
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 228
- 试验地点
- 23
- 主要终点
- 6-Minutes-Walking-Test (6MWT) in week 12
研究概览
简要总结
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).
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
- •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
排除标准
- •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
研究组 & 干预措施
Low dose group
Experimental
Low dose QiShen YiQi Dripping Pills, 3 bags, take orally after meals, 3 times a day
干预措施: Low dose QiShen YiQi Dripping Pills 3 bags (Drug)
High dose group
Experimental
High dose QiShen YiQi Dripping Pills, 3 bags, take orally after meals, 3 times a day
干预措施: High dose QiShen YiQi Dripping Pills 3 bags (Drug)
Placebo group
Placebo Comparator
QiShen YiQi Dripping Pills placebo, 3 bags, take orally after meals, 3 times a day
干预措施: QiShen YiQi Dripping Pills placebo 3 bags (Drug)
结局指标
主要结局
6-Minutes-Walking-Test (6MWT) in week 12
时间窗: Baseline to weeks 12
Change from baseline to weeks 12 in exercise capacity as measured by the 6-Minutes-Walking-Test (6MWT) distance.
次要结局
- 6-Minutes-Walking-Test (6MWT) in weeks 4 and 8(Baseline to weeks 4 and 8)
- Cardiovascular adverse events(Week 12)
- Echocardiogram results(Baseline to weeks 4,8 and 12)
- NYHA classification(Baseline to weeks 4,8 and 12)
- Traditional Chinese Medicine Syndrome Score(Baseline to weeks 4,8 and 12)
- Dyspnea, weakness, edema(Baseline to weeks 4,8 and 12)
- NT-proBNP(Baseline to weeks 4,8 and 12)
- Minnesota Living With Heart Failure Questionnaire(MLHFQ)(Baseline to weeks 4,8 and 12)
研究者
研究点 (23)
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