Cardiac dysfunction caused by anthracyclines
Conditions
Interventions
Experimental Group:Xijiaqi Granules
Control Group:Placebo
Sponsors
Dongzhimen Hospital Beijing University of Chinese Medieine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 80 years, inclusive; gender is not restricted. 2. Patients with pathologically or cytologically confirmed malignant neoplasm or hematological malignancy, who are either receiving anthracycline therapy or have completed anthracycline therapy within 1 year prior to screening. 3. Left ventricular ejection fraction (LVEF) =50%, with a decrease of =10% from the baseline (prior to anthracycline administration) and/or a decrease of global longitudinal strain (GLS) =15% and/or an elevation of new-onset cardiac biomarkers (high-sensitivity cardiac troponin [hs-cTn], B-type natriuretic peptide [BNP]/N-terminal pro-B-type natriuretic peptide [NT-proBNP]). 4. Eastern Cooperative Oncology Group (ECOG) performance status score < 2. 5. Estimated overall survival (OS) = 6 months. 6. Eligible for random assignment to the trial group and control group. 7. Voluntary participation in the trial and signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Diagnosed with dilated, restrictive, or hypertrophic cardiomyopathy, moderate or severe aortic and/or mitral valve disease. 2. Complicated with severe cardiac arrhythmias (e.g., ventricular asystole, frequent ventricular premature beats, ventricular tachycardia, ventricular fibrillation, etc.). 3. Present with cardiac lesions caused by other important organ disorders, such as pulmonary heart disease, right heart insufficiency complicated with liver cirrhosis, and thyrotoxic heart disease. 4. Patients with severe hypertension (systolic blood pressure =180 mmHg and/or diastolic blood pressure =110 mmHg) that cannot be effectively controlled despite antihypertensive medication. 5. Patients with ALT and AST levels exceeding 3 times the upper limit of normal, eGFR 5.5 mmol/L. 6. Patients previously treated with thoracic/mediastinal radiotherapy, immunosuppressants, or targeted therapies. 7. Patients with allergies to the components of the study drug or with contraindications to its use. 8. Currently enrolled in other clinical trials of drugs or external therapies. 9. Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| cardiac injury remission rate in the test and control groups; | — |
Secondary
| Measure | Time frame |
|---|---|
| myocardial injury markers;electrocardiography;echocardiogram; | — |
Countries
China
Contacts
Public ContactHongcai Shang
Dongfang Hospital Beijing University of chinese Medicine
Outcome results
None listed