Clinical Assessment of Complementary Treatment With Qishen Yiqi Dripping Pills on Ischemic Heart Failure (CACT-IHF) A Randomized, Double-blind, Multicenter, Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 640
- 试验地点
- 33
- 主要终点
- 6MWT distance
研究概览
简要总结
CACT-IHF aims to evaluate the clinical efficacy and safety of Qishen Yiqi Dripping Pills in treating ischemic heart failure. Meeting the diagnosis, inclusion and exclusion criteria, the study plans to recruit 640 cases from 35 upper class hospitals in China, who are divided into two groups (treatment and control group) by central randomization service. The treatment group will be administrated with one bag of Qishen Yiqi Dripping Pills (0.52g/bag) three times a day in addition to standardized western medications. Whereas the control group will be given one bag of Qishen Yiqi Dripping Pills dummy (0.52g/bag) three times a day in addition to standardized western medications. Efficacy indicators include primary indicator (6 minute walk test) and secondary indicators: composite endpoint consisting of all-cause death, emergency/re-admission to hospital due to HF, frequency of re-admission due to cardiovascular disease, acute coronary syndrome, severe arrhythmia, cardiac shock, revascularization, stroke, pulmonary embolism and peripheral vascular incidences, etc.; Brain Natriuretic Peptide; echocardiography; cardiothoracic ratio; NYHA cardiac function classification; Minnesota life quality scale; scores from the four traditional chinese medicine (TCM) diagnostic methods). Other indicators include blood cholesterol, triglyceride, high density cholesterol and low density cholesterol. Safety indicators include blood pressure, heart rate, blood and urine routine tests, liver and renal function tests, serum electrolytes, electrocardiogram and adverse events. All of the patients will receive interventional drug treatment for 6 months. Follow up is needed on the 1st, 3rd, 6th, 9th, 12th month after recruitment. All patients will be followed up until the end of study (Refers to the 12th month of the last case recruited into the study).
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 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 40 to 79
- •Patients with ischemic heart failure：
- •LVEF less than or equal to 45% measured by echocardiography in modified Simpson method
- •History of prior myocardial infarction with or without percutaneous coronary intervention (PCI) or/and coronary artery bypass grafting (CABG);
- •Coronary angiography (CAG) or coronary CTA shows more than or equal to 50% stenosis in at least one of the main coronary arteries with or without revascularization, of which the researcher thinks that it is closely related to heart failure;
- •With or without dyspnea, fatigue and fluid retention (edema) etc.
- •History of heart failure or present with heart failure symptoms for at least 3 months;
- •New York Heart Association (NYHA) Class II to IV;
- •Submitted informed consent
排除标准
- •Acute heart failure or acute exacerbation of chronic heart failure
- •Those who have one of the following diseases:
- •Acute coronary syndrome within 30 days
- •Revascularization therapy within 6 months
- •Uncontrolled hypertension with systolic pressure more than or equal to 180mmHg and/or diastolic pressure more than or equal to 110mmHg
- •Second degree type 2 or worse sinoatrial/atrioventricular block without implantation of pacemaker or uncontrolled malignant cardiac arrhythmia
- •Dilated cardiomyopathy
- •Hypertrophic obstructive cardiomyopathy
- •Myocarditis
- •Pulmonary artery embolism
- •Severe valvular heart disease
- •Pulmonary heart disease
- •Stroke within 6 months
- •Cardiac resynchronization therapy
- •Applied diuretics, cardiotonic agents or vasodilators intravenously within 7 days
- •Severe endocrine diseases such as hyperthyroidism, etc.
- •History of malignant tumor
- •Hemoglobin (HB )≤ 9g/dl
- •Alanine aminotransferase (ALT) > 2 times the upper limit of normal
- •Serum creatinine > 265 μmol/L
- •Mental disorder
- •Being pregnant, planning for pregnancy or breastfeeding
- •Suspicious or definite allergy to intervention drugs
- •Participated in other trials within 2 months
- •Unable to walk autonomously due to physical disabilities
研究组 & 干预措施
Qishen Yiqi dripping pills dummy
干预措施: Qishen Yiqi dripping pills dummy (Drug)
Qishen Yiqi Dripping Pills
干预措施: Qishen Yiqi Dripping Pills (Drug)
结局指标
主要结局
6MWT distance
时间窗: 0 month
6MWT
时间窗: 6th month
次要结局
- Composite endpoint(1st,3rd,6th,9th,12th month)
- Brain natriuretic peptide (BNP)(0,6th month)
- Echocardiography(0,6th month)
- Cardiothoracic Ratio(CR)(0,6th month)
- Cardiac function classification, NYHA(0,1st,3rd,6th,9th,12th month)
- Minnesota life quality scale(0,1st,3rd,6th,9th,12th month)
- Scores from the four TCM diagnostic methods(0,1st,3rd,6th,9th,12th month)
- blood and urine routine tests,liver and renal function tests,serum electrolytes,electrocardiogram (ECG)(0,3rd,6thmonth)
研究者
Jingyuan Mao
Prof.
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine