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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
80
participants will take matched 1800 mg YXS placebo pills TID in addition to the optimal combination drug treatment of heart failure
participants will take 1800 mg YXS pills TID in addition to the optimal combination drug treatment of heart failure
participants will take 20mg Trimetazidine pills TID in addition to the optimal combination drug treatment of heart failure
Dept. of Cardiology, Affiliated Zhongshan hospital of Dalian University
Dalian, Liaoning, China
RECRUITINGchange 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
Time frame: 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
Time frame: from baseline to 6 months
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.
Time frame: from baseline to 6 months
change in heart rate variability
assessed by Holter monitoring
Time frame: from baseline to 6 months
change in left ventricular end-systolic diameters (in millimeters)
assessed by echocardiographic examination
Time frame: from baseline to 6 months
change in left ventricular end-diastolic diameters (in millimeters)
assessed by echocardiographic examination
Time frame: from baseline to 6 months
change in left ventricular ejection fraction (in percentage)
assessed by echocardiographic examination
Time frame: from baseline to 6 months
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participants will take 1800 mg YXS and 20 mg Trimetazidine pills TID in addition to the optimal combination drug treatment of heart failure
change in exercise tolerance
assessed by the distance (in meters) walked on 6-minute walk test
Time frame: 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)
Time frame: 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
Time frame: from baseline to 6 months