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临床试验/NCT05816733
NCT05816733招募中4 期

Dapagliflozin Evaluation on Atrial Fibrillation Patients Followed Cox Maze IV Procedure: Prospective Randomized Trial (DETAIL-CMIV)

Kun Hua1 个研究点 分布在 1 个国家目标入组 348 人开始时间: 2023年9月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
招募中
发起方
入组人数
348
试验地点
1
主要终点
Rate of atrial fibrillation recurrence

研究概览

简要总结

Atrial fibrillation (AF) is the most common arrhythmia, which leads to reduced cardiac output and promotes the occurrence of heart failure, and abnormal hemodynamic changes in the left atrium induce thrombosis, which seriously reduces the quality of life, and even leads to death. For patients who need cardiac surgery combined with the Cox-Maze IV (CMIV) surgical ablation, oral amiodarone postoperatively for three consecutive months was recommended as the preferred treatment option. However, the study found there were still 15%-35% of patients at risk of AF recurrence. Dapagliflozin, a sodium-glucose cotransporter 2 inhibitor, has been widely used for the treatment of type 2 diabetes mellitus and heart failure. Nonetheless, it remains unknown whether dapagliflozin can improve the recurrence of AF and reduces adverse cardiovascular events for patients who need CMIV ablation, and whether it can be routinely used for AF patients without diabetes or heart failure. Therefore, this study aims to explore the effect of postoperative oral dapagliflozin on the recurrence of AF after CMIV.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥18 years
  • Patients with persistent or long-term persistent atrial fibrillation who need isolated surgical Cox-Maze IV procedure
  • Patients who need cardiac surgery combined with Cox-Maze IV procedure
  • Patients who have the ability and willingness to abide by all the subsequent reviews and requirements
  • Sign the informed consent

排除标准

  • Dapagliflozin allergy
  • Hyperthyroidism
  • Patients with acute myocardial infarction, cerebral apoplexy, and other vascular diseases during the past 6 months
  • Patients who received heart surgery within the last 3 months
  • eGFR<45ml/min
  • History of oral SGLT2i
  • Estimated survival period < 12 months
  • Pregnant and lactating women
  • Left atrial diameter > 65 mm
  • Refusing to sign the informed consent

研究组 & 干预措施

Dapagliflozin group

Experimental

Patients who will be randomized to receive dapagliflozin following the Cox-Maze IV Procedure.

干预措施: Dapagliflozin (Drug)

Placebo group

Placebo Comparator

Patients who will be randomized to receive placebo following the Cox-Maze IV Procedure.

干预措施: Placebo (Drug)

结局指标

主要结局

Rate of atrial fibrillation recurrence

时间窗: half of one year post operative

次要结局

  • Rate of atrial fibrillation recurrence(one year post operative)
  • Cardiovascular complex adverse events(one year post operative)

研究者

发起方
Kun Hua
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Kun Hua

Clinical Professor

Beijing Anzhen Hospital

研究点 (1)

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