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临床试验/NCT02575534
NCT02575534撤回不适用

Acute Mechanical Response to Anti-arrhythmic Drug Therapy

Evan Adelstein, MD1 个研究点 分布在 1 个国家开始时间: 2015年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
1
主要终点
changes in ejection fraction as measured via echocardiogram

研究概览

简要总结

The aim of this study is to determine if anti-arrhythmic drugs with a sodium channel-blocking mechanism exert a detrimental electromechanical effect on cardiac function in patients depending upon baseline intraventricular conduction and left ventricular function.

详细描述

Amiodarone therapy is used frequently for control of ventricular arrhythmias in patients who receive painful shocks from an implantable cardioverter-defibrillator (ICD). Data in post-myocardial infarction (MI) patients and ICD patients suggest that amiodarone is mortality-neutral; it neither confers increased nor decreased mortality. However, these data are derived from patients largely with normal intraventricular conduction, manifesting as a QRS complex duration on the surface ECG <120 ms. Amiodarone, in addition to potassium-channel blocking effects, is a sodium channel-blocker. Because sodium channels mediate cardiac depolarization, and a QRS complex >120 ms is indicative of abnormal depolarization, amiodarone may not be benign in patients with such conduction defects. Patients with cardiac resynchronization therapy-defibrillators (CRT-D), who all have abnormal baseline intraventricular conduction, may therefore be adversely affected by amiodarone. Anecdotal clinical data suggest that this may be the case, but the question of amiodarone's cardiac safety profile in CRT patients has never been studied.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Implanted cardiac device requiring generator change and a new device
  • Able to give informed consent

排除标准

  • Current membrane-active anti-arrhythmic
  • Glomerular filtration rate (GRF)<30 milliliters (mL)/min
  • MAP<60 mmHg
  • Known intolerance to procainamide
  • Pregnancy
  • Age <18 or >85 years old
  • Baseline QT interval >480 ms (500 ms if paced)

研究组 & 干预措施

observational

Experimental

All patients will undergo 12-lead ECG and transthoracic echocardiography on the day of the study. These studies will be performed on patients as their previously implanted device is reprogrammed to pace in different modes. Patients will then receive an infusion of procainamide (12 mg/kg up to a maximum of 1 g) at a rate of 20 mg/min. Repeat ECG and echocardiograms will then be performed.

The patient's device will be programmed to a specific setting before and after the procainamide infusion.

干预措施: Procainamide (Drug)

结局指标

主要结局

changes in ejection fraction as measured via echocardiogram

时间窗: baseline and 1hour post infusion

ejection fraction will be calculated via echocardiogram pre and post procainamide infusion.

changes in RV-LV electrical activation (in CRT patients)

时间窗: baseline and 1 hour post infusion

The RV-LV electrical activation will be assessed during the device interrogation pre and post procainamide infusion.

Change in QRS duration

时间窗: baseline and 1 hour post infusion

the QRS waveform measurements will be calculated on the EKG prior to and after the procainamide infusion

changes in left ventricular volumes as measured via echocardiogram

时间窗: baseline and 1 hour post infusion

the left ventricular volume will be calculated via echocardiogram pre and post procainamide infusion

次要结局

未报告次要终点

研究者

发起方
Evan Adelstein, MD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Evan Adelstein, MD

Evan Adelstein, MD

University of Pittsburgh

研究点 (1)

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