the Effects of YangXinShi (YXS) on the Quality of Life and Exercise Tolerance in Patients With Chronic Heart Failure
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- change in EQ-5D Questionnaire
研究概览
简要总结
The investigators set out to evaluate the effects of the traditional Chinese medicinal mixture under the brand name YangXinShi (YXS) on the prognosis in patients with chronic heart failure when it is combined with the optimal combination drug treatment of heart failure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients newly diagnosed with heart failure or have been diagnosed with chronic heart failure
- •patients classified as NYHA II-IV (New York Heart Association)
排除标准
- •with severe liver or renal dysfunction
- •with severe systematic conditions such as infection, malignant hypertension etc.
- •hemodynamic instability (arrhythmia, acute cardiac infarction, aortic dissection etc.)
- •not cooperating due to psychomotor deficiency, or with contraindications for exercise testing
研究组 & 干预措施
YanXinShi group
YanXinShi pills
干预措施: YanXinShi pills (Drug)
the control group
YanXinShi placebo pills
干预措施: YanXinShi placebo pills (Drug)
Trimetazidine group
Trimetazidine pills
干预措施: Trimetazidine pills (Drug)
YangXinShi and Trimetazidine group
YanXinShi and Trimetazidine pills
干预措施: YanXinShi and Trimetazidine pills (Drug)
结局指标
主要结局
change in EQ-5D Questionnaire
时间窗: from baseline to 6 months
health status measured in therms of five dimensions with the 5-level scale from 1-5, corresponding to having no problems and having extreme problems
change in EQ-VAS
时间窗: from baseline to 6 months
visual analogue scale (VAS) of EQ-5D Questionnaire scaled from 0-100, corresponding to the worse and the best health imagined
次要结局
- change in left ventricular ejection fraction (in percentage)(from baseline to 6 months)
- change in plasma N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels (in pg/ml)(from baseline to 6 months)
- change in heart rate variability(from baseline to 6 months)
- change in left ventricular end-diastolic diameters (in millimeters)(from baseline to 6 months)
- change in disease specific quality of life(from baseline to 6 months)
- change in left ventricular end-systolic diameters (in millimeters)(from baseline to 6 months)
- change in metabolic equivalents (METs)(from baseline to 6 months)
- change in exercise tolerance(from baseline to 6 months)