Acute Mechanical Response to Anti-arrhythmic Drug Therapy

Not Applicable

Withdrawn

• Conditions: Arrhythmias
• Interventions: Drug: Procainamide

• Registration Number: NCT02575534
• Lead Sponsor: Evan Adelstein, MD

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2015-06-16
• Study Start: 2015-10
• Study First Submitted QC: 2015-10-13
• Study First Posted: 2015-10-14
• Primary Completion: 2018-02-27
• Study Completion: 2018-02-27
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-26
• Last Update Posted: 2018-06-28

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
observational	Procainamide	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.

Primary Outcome Measures

Name	Time	Method
changes in ejection fraction as measured via echocardiogram	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)	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	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	baseline and 1 hour post infusion	the left ventricular volume will be calculated via echocardiogram pre and post procainamide infusion

Trial Locations

Locations (1)

Evan Adelstein; 🇺🇸 Pittsburgh, Pennsylvania, United States