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临床试验/NCT06082388
NCT06082388尚未招募不适用

Comparison of the Clinical Utility of Atropine and Isoprenaline in the Invasive Diagnosis of Arrhythmias

Medical University of Lodz1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年11月9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
尚未招募
入组人数
200
试验地点
1
主要终点
Evaluation of anterograde atrioventricular conduction

研究概览

简要总结

During electrophysiological study (EPS) multiple drugs are used to reveal arrhythmias and/or conductive system disorders. Two most often used agents are atropine and isoprenaline. Due to their distinct pharmacological properties, they are affecting myocardium in different manner. Those dissimilarities can affect the EPS course and long-term prognosis. The aim of presented study is to evaluate the optimal protocol of pharmacotherapy during EPS.

详细描述

Electrophysiological study (EPS) is essential tool for heart rhythm disorders diagnostic. Inducibility of arrhythmia before ablation to confirm the diagnosis and inability to do so after the procedure is crucial for long-term success. Multiple drugs are used to reveal arrhythmias and/or conductive system disorders. Two most often used are atropine and isoprenaline. Atropine is a natural, selective antagonist of cholinergic receptors M1 and M2. It reverses the inhibitory effect of vagal nerve on myocardium. This improves sinus node automatism and conduction in atrioventricular node. Isoprenaline is a preferential agonist of beta-1-adrenergic receptors. It has bathmotropic and chronotropic effect. During daily clinical practice those two drugs are often used interchangeably. However, differences in pharmacokinetics and pharmacodynamics may affect the results. There are lack of data directly comparing those two agents. There are isolated evidences that arrhythmia inducibility rate after the ablation differs between those two drugs. This may lead to the misconception of ablation as successful. The aim of presented study is to evaluate the optimal protocol of pharmacotherapy during EPS.

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

  • Patients with indication for electrophysiological study according to present guidelines of European Society of Cardiology

排除标准

  • Not willing or incapable to give written informed consent.
  • Previous diagnosed ventricle tachycardia or fibrillation
  • Previous diagnosed atrial fibrillation or flutter
  • Glaucoma (contraindication for atropine)

研究组 & 干预措施

Atropine

Active Comparator

Patients in whom during electrophysiological study atropine will be used. I.v. bolus of 0.01 mg/kg b.w. will be administered to reach the increase of heart rate of 25% or up to 130/min. If necessary, dose will be increased every 5 minutes until mention above parameters are achieved. Maximum dose will be 0.4 mg/kg b.w.

干预措施: Comparison of atropine and isoprenaline (Drug)

Isoprenaline

Active Comparator

Patients in whom during electrophysiological study isoprenaline will be used. Continuous i.v. infusion of 0.01 mcg/kg b.w./min will be administered to reach the increase of heart rate of 25% or up to 130/min. If necessary, dose will be doubled every 5 minutes until mention above parameters are achieved. Maximum dose will be 20 mcg/min.

干预措施: Comparison of atropine and isoprenaline (Drug)

结局指标

主要结局

Evaluation of anterograde atrioventricular conduction

时间窗: During the procedure

Anterograde Wenkebach point (ms) and effective refractory period of atrioventricular node (ms) during programed atrial stimulation will be assessed.

Evaluation of sino-atrial conduction time

时间窗: During the procedure

Sino-atrial conduction time (ms) during programed atrial stimulation will be assessed to examine the function of sinus node.

Evaluation of sinus node recovery time

时间窗: During the procedure

Sinus node recovery time (ms) during programed atrial stimulation will be assessed to examine the function of sinus node.

Long-term success rate

时间窗: 12 months

Recurrence of clinical arrhythmia during 12 months of observation

Arrhythmia inducibility

时间窗: During the procedure

Inducibility of anticipated arrythmia before and after drug administration and after eventual ablation.

Evaluation of retrograde atrioventricular conduction

时间窗: During the procedure

Retrograde Wenkebach point (ms) and effective refractory period of atrioventricular node (ms) during programed ventricular stimulation will be assessed.

次要结局

  • Incidence of adverse events during the electrophysiological study.(During the procedure)
  • Length of the procedure(During the procedure)
  • Incidence of adverse events during the 12-month follow up.(12 months)
  • Procedure time form drug administration till the end.(During the procedure)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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