Dapagliflozin vs. Standard Care for the Prevention of Atrial Fibrillation Early Recurrence After Catheter Ablation in Patients With Persistent Atrial Fibrillation: Rationale and Design of the DARE-AF Trial

Abstract Atrial fibrillation (AF) recurrence remains common after catheter ablation, particularly in patients with persistent AF (PeAF). Sodium-glucose cotransporter 2 inhibitors (SGLT2i) have been associated with a reduced risk of AF recurrence following ablation in patients with diabetes or heart failure. However, their efficacy in patients without class Ⅰ indications for SGLT2i remains uncertain. The DApagliflozin on REcurrence after catheter ablation for Atrial Fibrillation (DARE-AF) trial aims to evaluate the effect of dapagliflozin on AF burden following catheter ablation in patients with PeAF. DARE-AF is a prospective, parallel-group, randomized, open-label controlled trial. This study plans to enroll 200 patients with PeAF undergoing de novo catheter ablation. Patients with class Ⅰ indications for SGLT2i therapy (diabetes, heart failure, or chronic kidney disease) will be excluded. Patients will be randomized 1:1 to receive dapagliflozin 10 mg once daily for 3 months (intervention group) or guideline-directed standard care (control group). The primary endpoint is AF burden, assessed using 7-day single-lead electrocardiogram patches at 3 months after ablation. The primary endpoint will be evaluated by 2 blinded cardiologists with discrepancies adjudicated by a third blinded senior electrophysiologist. The results may provide novel insights into upstream rhythm control strategies in this population.