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临床试验/NCT05950971
NCT05950971终止不适用

Rhythm Control Versus Rate Control for New Onset Atrial Fibrillation After Non-cardiac Non-thoracic Surgery

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2021年7月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
终止
入组人数
1
试验地点
1
主要终点
Rate of sinus conversion

研究概览

简要总结

Adult patients who are diagnosed new onset atrial fibrillation with rapid ventricular response within 7 days after non-cardiac non-thoracic surgery are enrolled.

详细描述

After randomization, they are allocated to rhythm control strategy group or rate control strategy group. In rhythm control strategy group, patients are given amiodarone primarily for the purpose of sinus conversion of cardiac rhythm. In rate control strategy group, patients are given diltiazem or esmolol for the purpose of rate control. the rate of sinus conversion within 48 hours after treatment are compared.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

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

  • Older than 18 years
  • Newly diagnosed atrial fibrillation or flutter
  • Patients with atrial fibrillation or flutter that occurred within 7 days after non-cardiac non-thoracic surgery
  • Atrial fibrillation or flutter with rapid ventricular response(HR ≥110/min)
  • Patients without hemodynamic instability (MBP≥65mmHg with norepinephrine continuous infusion less than 5mcg/min or without vasopressor support)

排除标准

  • Atrial fibrillation or flutter prolonged more than 48 hours without anticoagulation
  • Patients who have decreased cardiac function or heart failure (EF <40%)
  • Patients who have cardiac conduction disorder, QT prolongation(QTc ≥500ms)

研究组 & 干预措施

Rate control strategy group

Experimental

Patients are given diltiazem or esmolol to control heart rate less than 110/min.

干预措施: Amiodarone, diltiazem or esmolol (Drug)

Rhythm control strategy group

Experimental

Patients are given amiodarone for conversion of cardiac rhythm to sinus rhythm.

干预措施: Amiodarone, diltiazem or esmolol (Drug)

结局指标

主要结局

Rate of sinus conversion

时间窗: within 48 hrs

Rate of sinus conversion within 48 hours

次要结局

  • Time to first sinus conversion(during the same admission period)
  • Recurrence of atrial fibrillation(during the same admission period)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ho Geol Ryu

Associate professor

Seoul National University Hospital

研究点 (1)

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