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

Primary Purpose

Arrhythmias

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Procainamide
Sponsored by
Evan Adelstein, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arrhythmias focused on measuring anti-arrhythmic therapy

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts 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)

Sites / Locations

  • Evan Adelstein

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

observational

Arm 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.

Outcomes

Primary Outcome Measures

Change in QRS duration
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
the left ventricular volume will be calculated via echocardiogram pre and post procainamide infusion
changes in ejection fraction as measured via echocardiogram
ejection fraction will be calculated via echocardiogram pre and post procainamide infusion.
changes in RV-LV electrical activation (in CRT patients)
The RV-LV electrical activation will be assessed during the device interrogation pre and post procainamide infusion.

Secondary Outcome Measures

Full Information

First Posted
June 16, 2015
Last Updated
June 26, 2018
Sponsor
Evan Adelstein, MD
Collaborators
University of Pittsburgh
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1. Study Identification

Unique Protocol Identification Number
NCT02575534
Brief Title
Acute Mechanical Response to Anti-arrhythmic Drug Therapy
Acronym
AAD and CRT
Official Title
Acute Mechanical Response to Anti-arrhythmic Drug Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Withdrawn
Why Stopped
No enrollment in study.
Study Start Date
October 2015 (Actual)
Primary Completion Date
February 27, 2018 (Actual)
Study Completion Date
February 27, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Evan Adelstein, MD
Collaborators
University of Pittsburgh

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arrhythmias
Keywords
anti-arrhythmic therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
observational
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Procainamide
Other Intervention Name(s)
procan
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in QRS duration
Description
the QRS waveform measurements will be calculated on the EKG prior to and after the procainamide infusion
Time Frame
baseline and 1 hour post infusion
Title
changes in left ventricular volumes as measured via echocardiogram
Description
the left ventricular volume will be calculated via echocardiogram pre and post procainamide infusion
Time Frame
baseline and 1 hour post infusion
Title
changes in ejection fraction as measured via echocardiogram
Description
ejection fraction will be calculated via echocardiogram pre and post procainamide infusion.
Time Frame
baseline and 1hour post infusion
Title
changes in RV-LV electrical activation (in CRT patients)
Description
The RV-LV electrical activation will be assessed during the device interrogation pre and post procainamide infusion.
Time Frame
baseline and 1 hour post infusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evan Adelstein, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Evan Adelstein
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22082198
Citation
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Results Reference
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PubMed Identifier
19917887
Citation
Packer DL, Prutkin JM, Hellkamp AS, Mitchell LB, Bernstein RC, Wood F, Boehmer JP, Carlson MD, Frantz RP, McNulty SE, Rogers JG, Anderson J, Johnson GW, Walsh MN, Poole JE, Mark DB, Lee KL, Bardy GH. Impact of implantable cardioverter-defibrillator, amiodarone, and placebo on the mode of death in stable patients with heart failure: analysis from the sudden cardiac death in heart failure trial. Circulation. 2009 Dec 1;120(22):2170-6. doi: 10.1161/CIRCULATIONAHA.109.853689. Epub 2009 Nov 16. Erratum In: Circulation. 2010 Feb 16;121(6):e39.
Results Reference
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PubMed Identifier
1900101
Citation
Echt DS, Liebson PR, Mitchell LB, Peters RW, Obias-Manno D, Barker AH, Arensberg D, Baker A, Friedman L, Greene HL, et al. Mortality and morbidity in patients receiving encainide, flecainide, or placebo. The Cardiac Arrhythmia Suppression Trial. N Engl J Med. 1991 Mar 21;324(12):781-8. doi: 10.1056/NEJM199103213241201.
Results Reference
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PubMed Identifier
1377359
Citation
Cardiac Arrhythmia Suppression Trial II Investigators. Effect of the antiarrhythmic agent moricizine on survival after myocardial infarction. N Engl J Med. 1992 Jul 23;327(4):227-33. doi: 10.1056/NEJM199207233270403.
Results Reference
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PubMed Identifier
9078198
Citation
Cairns JA, Connolly SJ, Roberts R, Gent M. Randomised trial of outcome after myocardial infarction in patients with frequent or repetitive ventricular premature depolarisations: CAMIAT. Canadian Amiodarone Myocardial Infarction Arrhythmia Trial Investigators. Lancet. 1997 Mar 8;349(9053):675-82. doi: 10.1016/s0140-6736(96)08171-8. Erratum In: Lancet 1997 Jun 14;349(9067):1776.
Results Reference
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PubMed Identifier
9078197
Citation
Julian DG, Camm AJ, Frangin G, Janse MJ, Munoz A, Schwartz PJ, Simon P. Randomised trial of effect of amiodarone on mortality in patients with left-ventricular dysfunction after recent myocardial infarction: EMIAT. European Myocardial Infarct Amiodarone Trial Investigators. Lancet. 1997 Mar 8;349(9053):667-74. doi: 10.1016/s0140-6736(96)09145-3. Erratum In: Lancet 1997 Apr 19;349(9059):1180. Lancet 1997 Jun 14;349(9067):1776.
Results Reference
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PubMed Identifier
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Citation
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Results Reference
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Acute Mechanical Response to Anti-arrhythmic Drug Therapy

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