Chronic Heart Failure
Conditions
Brief summary
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.
Interventions
DRUGYanXinShi placebo pills
participants will take matched 1800 mg YXS placebo pills TID in addition to the optimal combination drug treatment of heart failure
DRUGYanXinShi pills
participants will take 1800 mg YXS pills TID in addition to the optimal combination drug treatment of heart failure
DRUGTrimetazidine pills
participants will take 20mg Trimetazidine pills TID in addition to the optimal combination drug treatment of heart failure
DRUGYanXinShi and Trimetazidine pills
participants will take 1800 mg YXS and 20 mg Trimetazidine pills TID in addition to the optimal combination drug treatment of heart failure
Sponsors
Dalian University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in EQ-5D Questionnaire | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in left ventricular end-systolic diameters (in millimeters) | from baseline to 6 months | assessed by echocardiographic examination |
| change in left ventricular end-diastolic diameters (in millimeters) | from baseline to 6 months | assessed by echocardiographic examination |
| change in left ventricular ejection fraction (in percentage) | from baseline to 6 months | assessed by echocardiographic examination |
| change in disease specific quality of life | from baseline to 6 months | 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. |
| change in metabolic equivalents (METs) | from baseline to 6 months | measured as (volume of O2 (ml) consumption/kg/min) / (3.5 ml VO2/kg/min) |
| change in plasma N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels (in pg/ml) | from baseline to 6 months | assessed by blood tests |
| change in exercise tolerance | from baseline to 6 months | assessed by the distance (in meters) walked on 6-minute walk test |
| change in heart rate variability | from baseline to 6 months | assessed by Holter monitoring |
Countries
China
Contacts
Primary Contacthaoren wang, M.D., M.S.
Outcome results
None listed