Expired Study
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Pittsburgh, Pennsylvania 15213


Purpose:

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.


Study summary:

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.


Criteria:

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)


NCT ID:

NCT02575534


Primary Contact:

Principal Investigator
Evan Adelstein, MD
University of Pittsburgh


Backup Contact:

N/A


Location Contact:

Pittsburgh, Pennsylvania 15213
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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