ArticleFrontiers in cardiovascular medicine2026
Efficacy evaluation of Wenxin Keli in treating anthracycline-induced atrial arrhythmias (WARMA study): protocol for a multicenter, randomized, double-blind, placebo-controlled clinical trial.
Article in Frontiers in cardiovascular medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
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.
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