Acute Mechanical Response to Anti-arrhythmic Drug Therapy (AAD and CRT)

Evan Adelstein, MD

Status: Withdrawn

Conditions: Arrhythmias

Treatments: Drug: Procainamide

Study type: Interventional

Funder types: Other

Identifiers

NCT02575534

PRO14010486

Details and patient eligibility

About

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.

Full description

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.

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

observational

Experimental group

Description:

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.

Treatment:

Drug: Procainamide