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

June 26, 2018 updated by: Evan Adelstein, MD
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 Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Evan Adelstein

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: 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
Other Names:
  • procan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in QRS duration
Time Frame: baseline and 1 hour post infusion
the QRS waveform measurements will be calculated on the EKG prior to and after the procainamide infusion
baseline and 1 hour post infusion
changes in left ventricular volumes as measured via echocardiogram
Time Frame: baseline and 1 hour post infusion
the left ventricular volume will be calculated via echocardiogram pre and post procainamide infusion
baseline and 1 hour post infusion
changes in ejection fraction as measured via echocardiogram
Time Frame: baseline and 1hour post infusion
ejection fraction will be calculated via echocardiogram pre and post procainamide infusion.
baseline and 1hour post infusion
changes in RV-LV electrical activation (in CRT patients)
Time Frame: baseline and 1 hour post infusion
The RV-LV electrical activation will be assessed during the device interrogation pre and post procainamide infusion.
baseline and 1 hour post infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Evan Adelstein, MD

Collaborators

University of Pittsburgh

Investigators

  • Principal Investigator: Evan Adelstein, MD, University of Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2015

Primary Completion (Actual)

February 27, 2018

Study Completion (Actual)

February 27, 2018

Study Registration Dates

First Submitted

June 16, 2015

First Submitted That Met QC Criteria

October 13, 2015

First Posted (Estimate)

October 14, 2015

Study Record Updates

Last Update Posted (Actual)

June 28, 2018

Last Update Submitted That Met QC Criteria

June 26, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO14010486

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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