Acute Mechanical Response to Anti-arrhythmic Drug Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2018-02-27

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Arrhythmias

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Procainamide

Intervention Type DRUG

the procainamide will be infused at 12mcg/kg up to a max of 1 gram at a rate of 20mg/min which will take up to 1 hour to infuse

Interventions

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Procainamide

the procainamide will be infused at 12mcg/kg up to a max of 1 gram at a rate of 20mg/min which will take up to 1 hour to infuse

Intervention Type DRUG

Other Intervention Names

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procan

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes