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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| the control group | Placebo Comparator | YanXinShi placebo pills |
|
| YanXinShi group | Experimental | YanXinShi pills |
|
| Trimetazidine group | Active Comparator | Trimetazidine pills |
|
| YangXinShi and Trimetazidine group | Other | YanXinShi and Trimetazidine pills |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YanXinShi placebo pills | Drug | participants will take matched 1800 mg YXS placebo pills TID in addition to the optimal combination drug treatment of heart failure |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| haoren wang, M.D., M.S. | Contact | 08641162893507 | haoren_wang@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| qin yu, M.D., Ph.D. | Affiliated Zhongshan Hospital of Dalian University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. of Cardiology, Affiliated Zhongshan hospital of Dalian University | Recruiting | Dalian | Liaoning | 116001 | China |
age, gender, NYHA classification
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| YanXinShi pills | Drug | participants will take 1800 mg YXS pills TID in addition to the optimal combination drug treatment of heart failure |
|
| Trimetazidine pills | Drug | participants will take 20mg Trimetazidine pills TID in addition to the optimal combination drug treatment of heart failure |
|
| YanXinShi and Trimetazidine pills | Drug | participants will take 1800 mg YXS and 20 mg Trimetazidine pills TID in addition to the optimal combination drug treatment of heart failure |
|
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 |