Acute Mechanical Response to Anti-arrhythmic Drug Therapy
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
- 是
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
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
Evan Adelstein, MD
Evan Adelstein, MD
University of Pittsburgh
