PDF(Pubmed)
Abstract：
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.
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.
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.
摘要：
目的：达格列净已广泛用于治疗2型糖尿病（T2DM）和心力衰竭（HF）。然而,有关达格列净与心房颤动（AF）复发之间关联的数据，尤其是在CoxMazeIV（CMIV）之后的患者中，是罕见的。我们旨在探讨达格列净对伴有和不伴有T2DM或HF的CMIV后AF复发的影响。
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。
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。
