Anthracycline-related frequent ventricular premature beats
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Age 18-75 years old; (2) Patients who develop frequent premature ventricular contractions (PVCs) after anthracycline treatment indicated by a 24-hour Holter monitoring showing >500 PVCs/24 hours or paired/continuous PVCs ; (3) Diagnosed with Qi and Yin deficiency syndrome according to Traditional Chinese Medicine; (4) Voluntarily signed the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Severe coronary artery or valvular heart disease difficult to control with medication resulting in hemodynamic instability; (2) Pacemaker or ICD (Implantable Cardioverter Defibrillator) implantation; (3) Severe complications related to the primary tumor potentially life-threatening; (4) History of bleeding in the cerebrovascular gastrointestinal respiratory urinary tract or other organs within the last month; (5) Severe psychiatric disorders; (6) Allergy to the ingredients of the study medication; (7) Persistently elevated transaminase levels for unknown reasons (more than three times the upper normal limit); (8) Severe renal insufficiency: estimated glomerular filtration rate (eGFR) <45 mL/(min·1.73 m²); (9) Severe infection; (10) Pregnant or breastfeeding; (11) Concurrent oral use of cyclosporine; (12) Life expectancy of less than two years; (13) Participation in other clinical trials within the past month.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The reduction rate of frequent premature ventricular contractions (PVCs) caused by anthracycline drugs; | — |
Secondary
| Measure | Time frame |
|---|---|
| CKMB;Incidence of major adverse cardiovascular events (MACE);Changes in the symptom scores related to premature ventricular contractions (PVCs) after treatment;Traditional Chinese Medicine (TCM) syndrome score;cTnI;NT-proBNP; | — |
Countries
China
Contacts
Dongzhimen Hospital Beijing University of Chinese Medicine