Efficacy of Dapagliflozin on Recurrence after Catheter Ablation for Atrial Fibrillation: the Statistical Analysis Plan of the DARE-AF Trial

BackgroundAtrial fibrillation (AF) recurrence is common in patients after catheter ablation. Previous studies have demonstrated a lower risk of AF recurrence after ablation with the use of sodium-glucose cotransporter 2 inhibitors (SGLT2i) among patients with diabetes or heart failure. However, the effects of SGLT2i in AF patients after catheter ablation without current indications for SGLT2i were uncertain. ObjectiveThis trial aims to evaluate the effect of dapagliflozin on AF burden after ablation in persistent atrial fibrillation (PeAF) patients. Study DesignEfficacy of DApagliflozin on REcurrence after catheter ablation for Atrial Fibrillation (DARE-AF) is a parallel-group, randomized, open-label randomized controlled trial. We aim to enroll 200 patients with de novo atrial fibrillation (AF) undergoing catheter ablation, and patients with class I indications for SGLT2 Inh (diabetes, heart failure, or chronic kidney disease) are excluded. PeAF patients will be randomized in a 1:1 ratio to intervention or control group. Patients in the intervention group will receive dapagliflozin 10mg once daily for three months. The primary outcome is AF burden accessed by 7-day single-lead electrocardiogram patches at three months after ablation. ConclusionsDARE-AF is the first clinical trial, aiming to evaluate the effect of 3-month treatment with dapagliflozin on AF burden after catheter ablation in PeAF patients without current indications.