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.
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.
方法:达格列净评估房颤患者的Cox-MazeIV(DETAIL-CMIV)是一项前瞻性研究,双盲,随机化,安慰剂对照试验。共240名接受过CMIV手术的房颤患者将被随机分为达格列净组(10mg/day,n=120)和安慰剂组(10mg/天,n=120)并治疗3个月。主要终点是任何有记录的房性快速性心律失常(AF,房扑或房性心动过速[AF/AT])在CMIV后3个月的消隐期后持续30s。
结论:DETAIL-CMIV将确定SGLT2抑制剂达格列净是否,增加了指南推荐的术后房颤治疗,在有和没有T2DM或HF的患者中安全地降低AF的复发率。
背景:NCT05816733。