Atrial arrhythmias caused by anthracyclines
Conditions
Interventions
Control Group:Starting on day 1 of enrollment, placebo was given orally, 1 sachet at a time, 3 times a day, in addition to the basal medication, for an intervention cycle of 3 months.
Experimental Group:Starting from the first day of enrollment on top of the basic medication Wenxin Keli were given orally 1 sachet at a time 3 times a day and the intervention cycle was 3 months.
Sponsors
Guang'anmen Hospital China Academy of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: (1) Age 18–80 years; (2) Having a confirmed pathological type, receiving chemotherapy for the first time, and presenting with atrial premature beats or atrial fibrillation after at least one cycle of anthracycline therapy, with ambulatory electrocardiography showing atrial premature beats =360 beats/24 h or meeting the diagnostic criteria for atrial fibrillation; (3) No history of atrial premature beats or atrial fibrillation; (4) No prior history of chest radiotherapy, targeted therapy, or immunotherapy; (5) Eastern Cooperative Oncology Group (ECOG) performance status <2; (6) Willing to be randomly assigned to either the Wenxin Granule group or the control group; (7) Voluntary participation in the trial and provision of signed informed consent.
Exclusion criteria
Exclusion criteria: (1) Patients with inadequately controlled heart failure (left ventricular ejection fraction 500 ms, a history of QTc prolongation (congenital or acquired), or severe bradyarrhythmia; (3) Patients with newly diagnosed major vascular events within the past 3 months, such as myocardial infarction or cerebral infarction; (4) Patients with diagnosed cardiomyopathy (ischemic, dilated, restrictive, or hypertrophic) or moderate to severe valvular heart disease; (5) Patients with inadequately controlled blood pressure: systolic blood pressure =180 mmHg or diastolic blood pressure =110 mmHg, or systolic blood pressure 5.5 mmol/L; (8) Patients with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels exceeding three times the upper limit of normal; (9) Pregnant or lactating women; (10) Patients with known allergy or contraindications to the components of the investigational drug; (11) Patients currently participating in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of atrial arrhythmia-free patients in both groups post-intervention; | — |
Secondary
| Measure | Time frame |
|---|---|
| electrocardiogram;24-hour ambulatory electrocardiogram;Echocardiogram;Changes in the number of atrial contractions;Atrial fibrillation load;cTnI;BNP/NT-proBNP; | — |
Countries
China
Contacts
Public ContactYanwei Xing
Guang'anmen Hospital China Academy of Traditional Chinese Medicine
Outcome results
None listed