Rationale and design of a randomized trial of the dapagliflozin evaluation on atrial fibrillation patients followed Cox-Maze IV: the DETAIL-CMIV study

Europace. 2023 Nov 2;25(11):euad333. doi: 10.1093/europace/euad333.

Abstract

Aims: Dapagliflozin has been widely used for the treatment of type 2 diabetes mellitus (T2DM) and heart failure (HF). However, data concerning the association between dapagliflozin and the recurrence of atrial fibrillation (AF), especially in patients following Cox-Maze IV (CMIV), are rare. We aim to explore the effect of dapagliflozin on the recurrence of AF after CMIV with and without T2DM or HF.

Methods and results: The study of dapagliflozin evaluation in AF patients followed by CMIV (DETAIL-CMIV) is a prospective, double-blind, randomized, placebo-controlled trial. A total of 240 AF patients who have received the CMIV procedure will be randomized into the dapagliflozin group (10 mg/day, n = 120) and the placebo group (10 mg/day, n = 120) and treated for 3 months. The primary endpoint is any documented atrial tachyarrhythmia (AF, atrial flutter or atrial tachycardia) lasting 30 s following a blanking period of 3 months after CMIV.

Conclusion: DETAIL-CMIV will determine whether the sodium-glucose cotransporter-2 inhibitor dapagliflozin, added to guideline-recommended post-operative AF therapies, safely reduces the recurrence rate of AF in patients with and without T2DM or HF.

Keywords: Atrial fibrillation; Cox-Maze IV; Dapagliflozin; Recurrence.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Atrial Fibrillation* / diagnosis
  • Atrial Fibrillation* / drug therapy
  • Atrial Fibrillation* / surgery
  • Catheter Ablation* / methods
  • Diabetes Mellitus, Type 2* / complications
  • Diabetes Mellitus, Type 2* / diagnosis
  • Diabetes Mellitus, Type 2* / drug therapy
  • Heart Failure* / surgery
  • Humans
  • Prospective Studies
  • Sodium-Glucose Transporter 2 Inhibitors* / adverse effects
  • Treatment Outcome

Substances

  • dapagliflozin
  • Sodium-Glucose Transporter 2 Inhibitors