the Effects of YangXinShi (YXS) on the Quality of Life and Exercise Tolerance in Patients With Chronic Heart Failure

Study Overview
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Brief Summary
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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.

Official Title
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the Effects of YangXinShi (YXS) on the Quality of Life and Exercise Tolerance in Patients With Chronic Heart Failure

Conditions
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Chronic Heart Failure

Intervention / Treatment
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* Drug: YanXinShi placebo pills
* Drug: YanXinShi pills
* Drug: Trimetazidine pills
* Drug: YanXinShi and Trimetazidine pills


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients newly diagnosed with heart failure or have been diagnosed with chronic heart failure patients classified as NYHA II-IV (New York Heart Association) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: the control group<br>YanXinShi placebo pills | Drug: YanXinShi placebo pills<br>* participants will take matched 1800 mg YXS placebo pills TID in addition to the optimal combination drug treatment of heart failure<br>|
| Experimental: YanXinShi group<br>YanXinShi pills | Drug: YanXinShi pills<br>* participants will take 1800 mg YXS pills TID in addition to the optimal combination drug treatment of heart failure<br>|
| Active Comparator: Trimetazidine group<br>Trimetazidine pills | Drug: Trimetazidine pills<br>* participants will take 20mg Trimetazidine pills TID in addition to the optimal combination drug treatment of heart failure<br>|
| Other: YangXinShi and Trimetazidine group<br>YanXinShi and Trimetazidine pills | Drug: YanXinShi and Trimetazidine pills<br>* participants will take 1800 mg YXS and 20 mg Trimetazidine pills TID in addition to the optimal combination drug treatment of heart failure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in EQ-5D Questionnaire | 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 | from baseline to 6 months | 
| change in EQ-VAS | visual analogue scale (VAS) of EQ-5D Questionnaire scaled from 0-100, corresponding to the worse and the best health imagined | from baseline to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in disease specific quality of life | assessment of disease-related QoL using Kansas City Cardiomyopathy Questionnaire (KCCQ-12) with 7 heart failure domains. Scores of each domain are scaled from 0-100, with 0 corresponding to the worst, 100 the best status. | from baseline to 6 months | 
| change in heart rate variability | assessed by Holter monitoring | from baseline to 6 months | 
| change in left ventricular end-systolic diameters (in millimeters) | assessed by echocardiographic examination | from baseline to 6 months | 
| change in left ventricular end-diastolic diameters (in millimeters) | assessed by echocardiographic examination | from baseline to 6 months | 
| change in left ventricular ejection fraction (in percentage) | assessed by echocardiographic examination | from baseline to 6 months | 
| change in exercise tolerance | assessed by the distance (in meters) walked on 6-minute walk test | from baseline to 6 months | 
| change in metabolic equivalents (METs) | measured as (volume of O2 (ml) consumption/kg/min) / (3.5 ml VO2/kg/min) | from baseline to 6 months | 
| change in plasma N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels (in pg/ml) | assessed by blood tests | from baseline to 6 months |