PMID- 37939825 OWN - NLM STAT- MEDLINE DCOM- 20231120 LR - 20240115 IS - 1532-2092 (Electronic) IS - 1099-5129 (Print) IS - 1099-5129 (Linking) VI - 25 IP - 11 DP - 2023 Nov 2 TI - Rationale and design of a randomized trial of the dapagliflozin evaluation on atrial fibrillation patients followed Cox-Maze IV: the DETAIL-CMIV study. LID - 10.1093/europace/euad333 [doi] LID - euad333 AB - 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. CI - (c) The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology. FAU - Peng, Zhan AU - Peng Z AUID- ORCID: 0000-0002-4621-1968 AD - Department of Cardiovascular Surgery, Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart, Lung and Vessel Disease, 2# Anzhen Road, Cao Yang District, Beijing 100029, China. FAU - Osmanaj, Florian AU - Osmanaj F AD - Department of Cardiovascular Surgery, Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart, Lung and Vessel Disease, 2# Anzhen Road, Cao Yang District, Beijing 100029, China. FAU - Yang, Yunxiao AU - Yang Y AUID- ORCID: 0000-0001-7921-2484 AD - Department of Cardiovascular Surgery, Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart, Lung and Vessel Disease, 2# Anzhen Road, Cao Yang District, Beijing 100029, China. FAU - Hua, Kun AU - Hua K AUID- ORCID: 0000-0002-2189-3632 AD - Department of Cardiovascular Surgery, Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart, Lung and Vessel Disease, 2# Anzhen Road, Cao Yang District, Beijing 100029, China. FAU - Yang, Xiubin AU - Yang X AUID- ORCID: 0009-0008-2318-5227 AD - Department of Cardiovascular Surgery, Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart, Lung and Vessel Disease, 2# Anzhen Road, Cao Yang District, Beijing 100029, China. LA - eng PT - Journal Article PT - Randomized Controlled Trial PL - England TA - Europace JT - Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology JID - 100883649 RN - 1ULL0QJ8UC (dapagliflozin) RN - 0 (Sodium-Glucose Transporter 2 Inhibitors) SB - IM MH - Humans MH - *Atrial Fibrillation/diagnosis/drug therapy/surgery MH - Prospective Studies MH - *Diabetes Mellitus, Type 2/complications/diagnosis/drug therapy MH - *Sodium-Glucose Transporter 2 Inhibitors/adverse effects MH - *Catheter Ablation/methods MH - *Heart Failure/surgery MH - Treatment Outcome PMC - PMC10655060 OTO - NOTNLM OT - Atrial fibrillation OT - Cox-Maze IV OT - Dapagliflozin OT - Recurrence COIS- Conflict of interest: None declared EDAT- 2023/11/09 00:42 MHDA- 2023/11/20 06:55 PMCR- 2023/11/06 CRDT- 2023/11/08 19:14 PHST- 2023/07/18 00:00 [received] PHST- 2023/11/02 00:00 [accepted] PHST- 2023/11/20 06:55 [medline] PHST- 2023/11/09 00:42 [pubmed] PHST- 2023/11/08 19:14 [entrez] PHST- 2023/11/06 00:00 [pmc-release] AID - 7367867 [pii] AID - euad333 [pii] AID - 10.1093/europace/euad333 [doi] PST - ppublish SO - Europace. 2023 Nov 2;25(11):euad333. doi: 10.1093/europace/euad333.