Heart Failure
Conditions
Brief summary
Evaluate the efficacy and safety of Jia Shen Tablets in patients with Chronic Heart Failure.
Interventions
DRUGJia Shen Tablet Placebo
Jia Shen Tablet Placebo contains 4 placebo tablets (0.47 g per placebo tablet),take orally, 2 times a day for 12 weeks
DRUGLow dose Jia Shen Tablet
Low dose Jia Shen Tablet contains 2 tablets (0.47 g per tablet) and 2 placebo tablets (0.47 g per placebo tablet),take orally, 2 times a day for 12 weeks
DRUGHigh dose Jia Shen Tablet
High dose Jia Shen Tablet contains 4 tablets (0.47 g per tablet),take orally, 2 times a day for 12 weeks
Sponsors
Tasly Pharmaceutical Group Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* Age 40-79 years, either sex; * Meet the diagnostic criteria for CHD and CHF; * Meet the TCM differentiation criteria of yang qi deficiency and blood stasis in CHF; * Class Ⅱ to Ⅲ for NYHA functional classification; * Willing to provide written informed consent.
Exclusion criteria
* CHF with acute exacerbation or intravenous drug therapy; * Received cardiac resynchronization therapy (CRT) or other heart failure devices; * Within 3 months before randomization, acute coronary syndrome（ACS）, stroke or transient ischemic attack（TIA） occurred or received cardiac revascularization (PCI, CABG); * Plan to undergo cardiac revascularization (PCI, CABG) or cardiac resynchronization therapy (CRT) during the trial period; * Severe arrhythmias \[such as persistent atrial fibrillation, permanent atrial fibrillation, ventricular tachycardia, second-degree type II or higher sinus or atrioventricular block without pacemaker placement, QT interval (QTc) exceeding 480 ms after heart rate adjustment according to Fridericia's formula, or known history or symptoms of long QT syndrome\]; * Severe hypertension (systolic blood pressure ≥180mm Hg or diastolic blood pressure ≥110mm Hg) or hypotension (systolic blood pressure \< 90 mmHg); * Heart failure caused by other cardiovascular diseases such as congenital heart disease, severe stenosis or insufficiency of heart valves, cardiomyopathy (e.g. hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy, dilated cardiomyopathy, alcoholic cardiomyopathy), moderate pericardial effusion, constrictive pericarditis, and infective endocarditis; * Combined with liver, kidney, hematopoietic system and other serious primary diseases, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) more than 3 times the upper limit of local laboratory normal value, the estimated glomerular filtration rate (eGFR) \< 30 ml/min/1.73m2, Blood potassium \> 5.5 mmol/L or hemoglobin (Hb) \< 90 g/L; Malignant tumors, severe neuroendocrine system diseases and mental diseases; * Pregnant or lactating; * Participating in other interventional clinical studies within 1 month before screening; * Allergic constitution, or allergic to Chinese medicines of Jia Shen Tablets (such as Periploca sepium, salvia miltiorrhiza, etc.); * The investigator determines that the patient is unable to complete the study or comply with the requirements of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6-Minutes-Walking-Distance (6MWD): the change from baseline to Week 12. | Baseline and Week 12. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| NT-proBNP: the change from baseline to Week 6 and 12. | Baseline, Week 6 and 12. | — |
| NT-proBNP: the proportion of patients demonstrating a decrease in NT-proBNP level of at least 30%. | Baseline, Week 6 and 12. | — |
| Echocardiogram: Measurements will be made of the left ventricle's end diastolic diameter (LVEDD), end diastolic volume (LVEDV), end systolic volume (LVESV), left ventricular ejection fraction（LVEF）, stroke volume (SV), and cardiac output (CO). | Baseline and Week 12. | — |
| NYHA functional classification: Measure the percentage of participants whose NYHA functional classification is improved/worsened/unchanged from baseline to Week 6 and 12. | Baseline, Week 6 and 12. | — |
| 6-Minutes-Walking-Distance (6MWD): the change from baseline to Week 6. | Baseline and Week 6. | — |
| Traditional Chinese Medicine（TCM） Syndrome Score: change from baseline to Week 6 and 12. | Baseline, Week 6 and 12. | There were 3 primary symptoms and 4 secondary symptoms. The state of the tongue and pulse is used to evaluate and score TCM symptoms. The standard of TCM primary symptoms scored as without 0, light 2, medium 4, heavy 6 points. The standard of TCM secondary symptoms scored as without 0, light 1, medium 2, heavy 3 points. Tongue picture and pulse condition did not count. |
| Dyspnea, weakness and edema: the rate of disappearance of the symptoms (dyspnea, weakness, and edema) from baseline to Week 6 and 12. | Baseline, Week 6 and 12. | — |
| Cardiovascular Adverse Events: Incidence of Cardiovascular AEs（cardiovascular death, hospitalization for worsening heart failure, hospitalization for nonfatal myocardial infarction, hospitalization for nonfatal stroke）. | Week 12. | — |
| MLHFQ Score: the change from baseline to Week 6 and 12. | Baseline, Week 6 and 12. | The MLHFQ consists of 21 elements representing varying degrees of impact of HF on health related quality of life. Each item in this questionnaire is scored from 0 (none) to 5 (very much), and the total item score is from 0 (none) to 105 (very much). |
Countries
China
Contacts
Primary ContactRui Liu
Outcome results
None listed