Coronary Heart Disease, Cardiac Dysfunction
Conditions
Keywords
Yangxinshi, Coronary heart disease, Cardiac dysfunction
Brief summary
A randomized controlled trial was conducted to evaluate the efficacy and safety of Yangxinshi tablets in improving the condition of patients with coronary heart disease complicated by cardiac dysfunction.
Detailed description
The purpose of this study was to investigate whether the addition of Yangxinshi tablets to conventional treatment can reduce the composite endpoint time, increase exercise tolerance, and improve quality of life and mental health in patients with coronary heart disease complicated by cardiac dysfunction. A total of 2708 eligible patients were randomly divided into two groups. In addition to conventional treatment, the trial group was given Yangxinshi tablets (3 tablets/time, 3 times/day), while the control group was a blank control. The treatment cycle continued until the expected number of endpoint events was reached or the study ended, whichever occurred first. The primary endpoint was the composite endpoint of ischemic events or heart failure-related clinical events (including all-cause death, ischemia-driven revascularization, stroke, myocardial infarction (MI), and readmission due to aggravated ACS or heart failure) during the study period.
Interventions
Basic treatment: All patients received a conventional treatment regimen, including outcome-improving drugs (aspirin, P2Y12 receptor inhibitor、β-blockers, statins, ARNI /ACEI/ARB, SGLT2i, and MRA) and symptom-relieving drugs (nitrates, calcium antagonists, and loop diuretic). Trial drug: Yangxinshi tablets, 3 tablets/3 times a day, taken orally
DRUGBlank control
Basic treatment: All patients received a conventional treatment regimen, including outcome-improving drugs (aspirin, P2Y12 receptor inhibitor、β-blockers, statins, ARNI /ACEI/ARB, SGLT2i, and MRA) and symptom-relieving drugs (nitrates, calcium antagonists, and loop diuretic). Trial drug: Blank control
Sponsors
SPH Qingdao Growful Pharmacetical Co.,Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. For inpatients diagnosed with coronary heart disease (including acute coronary syndrome and chronic coronary syndrome), it is up to the doctor to decide whether to undergo revascularization and what kind of revascularization to use. 2. Patients aged between 40 and 80 years (inclusive), regardless of sex; 3. Patients with NYHA cardiac function classes II-IV; 4. Patients with NT-proBNP \> 125 pg/mL (or BNP\>35 pg/mL); 5. The syndrome differentiation in traditional Chinese medicine conforms to chest obstruction (qi deficiency and blood stasis syndrome) 6. Patients who voluntarily participated and signed an informed consent form.
Exclusion criteria
1. Patients with STEMI within 3 days; 2. Patients at extremely high risk of NSTEMI (hemodynamic instability, cardiogenic shock, new-onset heart failure or aggravated heart failure, severe ventricular arrhythmia) 3. Patients with acute myocardial infarction complicated with cardiogenic shock, mechanical complications, respiratory failure and other multiple organ failure; 4. Patients with severe liver dysfunction (transaminase levels more than three times the upper limit of normal), renal insufficiency (eGFR \< 30mL/min/1.73m2), acute infectious diseases, and mental disorders;以上翻译结果来自有道神经网络翻译（YNMT）· 通用场景 5. Patients with drug-resistant hypertension (systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg); 6. Pregnant or lactating women, or those planning pregnancy during the study period; 7. Patients who cannot tolerate 3 months of dual antiplatelet therapy; 8. Patients with allergic reactions or abnormal drug reactions to the study drug or any of its excipients; 9. Patients who have regularly taken Yangxinshi tablets and similar traditional Chinese medicine, Chinese patent medicine or traditional Chinese medicine decoction with the same curative effectin the past month; 10. Patients who have participated in other clinical drug trials within the last three months; 11. Patients with malignant tumors and other pathological conditions with an expected survival of less than 3 years; 12. Patients whom the investigator deems unsuitable for participating in the clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The composite endpoint was ischemic events or heart failure-related clinical events | Through study completion, an average of 3 years | All-cause death, ischemia-driven revascularization, stroke, MI, and readmission due to aggravated ACS or heart failure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Readmission due to aggravated heart failure | Through study completion, an average of 3 years | Readmission due to aggravated heart failure |
| NT-proBNP or BNP | From baseline at 48 weeks | Measurement of NT-proBNP or BNP, calculation of the proportion of patients achieving NT-proBNP \<125 pg/mL (or BNP \<35 pg/mL), and the degree of reduction |
| Patient Health Questionnaire - 9(PHQ-9) depression scale | After 24 and 48 weeks of treatment | The Patient Health Questionnaire - 9(PHQ-9)depression scale comprises nine questions. In each assessment area, scores range from 0 to 3 based on the increasing frequency of difficult: 0 indicates not at all, 1 indicates sometimes, 2 indicates more than half the time, and 3 indicates almost every day. The total score ranges from 0 to 27,higher scores mean a worse outcome. |
| Generalized Anxiety Disorder 7 - item Scale(GAD-7) anxiety scale | After 24 and 48 weeks of treatment | The Generalized Anxiety Disorder 7 - item Scale(GAD-7) anxiety scale comprises seven questions. In each assessment area, scores range from 0 to 3 based on the increasing frequency of difficult: 0 indicates not at all, 1 indicates sometimes, 2 indicates more than half the time, and 3 indicates almost every day. The total score ranges from 0 to 21,higher scores mean a worse outcome. |
| NYHA | After 24 and 48 weeks of treatment | Changes in New York Heart Association (NYHA) functional classification |
| SAQ | After 24 and 48 weeks of treatment | Changes in Seattle Angina Questionnaire (SAQ) scores.The SAQ scale is divided into 5 dimensions, with a total of 19 items, and each item is scored out of 100 points. The higher the score, the better the therapeutic effect |
| KCCQ-OS | After 24 and 48 weeks of treatment | Changes in Kansas City Cardiomyopathy Questionnaire overall score (KCCQ-OS) compared to baseline.The total score ranges from 0 to 100,higher scores mean a better outcome. |
| Echocardiography | After 48 weeks of treatment | Changes from baseline examined via echocardiography, including left ventricular systolic function (left ventricular end-diastolic diameter (LVDd), left ventricular end-systolic diameter (LVSd), left ventricular ejection fraction (LVEF), left ventricular fractional shortening (FS) and left ventricular diastolic function (E/A and E/e) . When possible, the left ventricular global longitudinal strain rate (LVGLS) was also measured |
| Metabolic equivalents(METs) | After 48 weeks of treatment | Changes in metabolic equivalents(METs) determined by cardiopulmonary exercise testing in some patients. |
| Anaerobic thresholds (ATs) | After 48 weeks of treatment | Changes in anaerobic thresholds (ATs) determined by cardiopulmonary exercise testing in some patients. |
| Maximal oxygen consumption (VO2max) | After 48 weeks of treatment | Changes in maximal oxygen consumption (VO2max) determined by cardiopulmonary exercise testing in some patients. |
| VO2/heart rate(HR) | After 48 weeks of treatment | Changes in VO2/HR determined by cardiopulmonary exercise testing in some patients. |
| Ischemic composite endpoint events | Through study completion, an average of 3 years | Cardiovascular and cerebrovascular death, MI, ischemia-driven revascularization, stroke, and readmission due to ACS |
| Heart failure-related clinical events | Through study completion, an average of 3 years | Readmission due to aggravated heart failure or all-cause death |
| Cardiovascular and cerebrovascular deaths | Through study completion, an average of 3 years | Occurrence of cardiovascular and cerebrovascular deaths |
| All-cause death | Through study completion, an average of 3 years | Occurrence of all-cause death |
| Readmission due to ACS | Through study completion, an average of 3 years | Readmission due to ACS |
| The cumulative incidence of readmission due to aggravated ACS or heart failure | Through study completion, an average of 3 years | The joint gamma frailty model was adopted for analysis |
| Win ratio | Through study completion, an average of 3 years | The main efficacy indicators were analyzed by using the win ratio method |
| 6MWD | From baseline at 48 weeks | Change in 6-minute walking distance |
| The ratio of the change in VO2 to the change in the work rate (△VO2/△WR) | After 48 weeks of treatment | Changes in △VO2/△WR determined by cardiopulmonary exercise testing in some patients. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 12-lead Electrocardiogram (ECG) | After 24 and 48 weeks of treatment | 12-lead ECG consists of Ⅰ、Ⅱ、Ⅲ、aVR、aVL、aVF、V1、V2、V3、V4、V5、V6.ECG consists of P wave, PR interval, QRS complex, ST segment, and T wave. |
| White blood cell (WBC) count | After 24 and 48 weeks of treatment | Normal value: 4-10, unit: 109/L.Check at 24 and 48 weeks to see if it is within the normal range. |
| Red blood cell (RBC) count | After 24 and 48 weeks of treatment | Normal value: 3.5-5, unit: 1012/L.Check at 24 and 48 weeks to see if it is within the normal range. |
| Hemoglobin (Hb) level | After 24 and 48 weeks of treatment | Normal value: 110-150, unit: g/L.Check at 24 and 48 weeks to see if it is within the normal range. |
| Platelet (PLT) count | After 24 and 48 weeks of treatment | Normal value: 100-300,unit: 109/L.Check at 24 and 48 weeks to see if it is within the normal range. |
| Liver function test | After 24 and 48 weeks of treatment | Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) |
| Serum creatinine concentration | After 24 and 48 weeks of treatment | Unit: μmol /L |
| Estimated glomerular filtration rate (eGFR) | After 24 and 48 weeks of treatment | Unit: ml/minute.Calculated using the Modification of Diet in Renal Disease (MDRD) equation |
| Adverse events | Through study completion, an average of 3 years | Adverse events/serious adverse events |
| Blood pressure | After 24 and 48 weeks of treatment | Systolic and diastolic,unit: mmHg |
| Heart rate | After 24 and 48 weeks of treatment | Unit: beats /minute |
Countries
China
Contacts
Primary ContactHan ya ling
Outcome results
None listed