Efficacy evaluation of Wenxin Keli in treating anthracycline-induced atrial arrhythmias (WARMA study): protocol for a multicenter, randomized, double-blind, placebo-controlled clinical trial

Background Anthracycline-induced cardiotoxicity is a major factor affecting the long-term prognosis of cancer patients. Atrial arrhythmias, as common manifestations of cardiotoxicity, significantly impair quality of life and may compromise the effectiveness of anticancer therapy, representing a significant clinical challenge. Wenxin Keli (WXKL), a traditional Chinese medicine formulation with the effects of replenishing qi, nourishing yin, and promoting blood circulation, has demonstrated potential anti-arrhythmic benefits. However, high-quality evidence supporting its application in the field of cardio-oncology remains limited. This study aims to systematically evaluate the efficacy and safety of WXKL in patients with anthracycline-induced atrial arrhythmias. Methods This is a multicenter, randomized, double-blind, placebo-controlled clinical trial. A total of 152 eligible participants will be enrolled and randomly assigned to receive either WXKL or placebo for 3 months, followed by a 3-month follow-up period. The primary outcome is the proportion of patients free from atrial arrhythmias at 3 months, defined as the absence of atrial fibrillation (AF) episodes lasting ≥30 s or premature atrial contractions (PACs) ≥100 beats per 24 h on Holter monitoring. Secondary outcomes include AF burden, PACs count, echocardiographic parameters, cardiac biomarkers (cTnI and NT-proBNP), quality of life (FACT-G), functional status (ECOG), clinical symptom scores, and anxiety scores (SAS) at 3 and 6 months, as well as safety assessments. Discussion This study is designed to provide high-level clinical evidence for the use of WXKL in the treatment of anthracycline-induced atrial arrhythmias. By incorporating both PACs and AF as a composite endpoint, the study aims to more comprehensively capture the overall burden and dynamic progression of atrial arrhythmias, and to inform cardio-protective strategies during cancer therapy. Trial registration: http://itmctr.ccebtcm.org.cn/zh-CN , International Traditional Medicine Clinical Trial Registry Platform, ITMCTR2025000704.