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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02575534
Recruitment Status : Withdrawn (No enrollment in study.)
First Posted : October 14, 2015
Last Update Posted : June 28, 2018
Sponsor:
Collaborator:
University of Pittsburgh
Information provided by (Responsible Party):
Evan Adelstein, MD, University of Pittsburgh

Study Description
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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.

Condition or disease Intervention/treatment Phase
Arrhythmias Drug: Procainamide Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Acute Mechanical Response to Anti-arrhythmic Drug Therapy
Actual Study Start Date : October 2015
Actual Primary Completion Date : February 27, 2018
Actual Study Completion Date : February 27, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: procan


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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

  3. 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.

  4. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02575534


Locations
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United States, Pennsylvania
Evan Adelstein
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Evan Adelstein, MD
University of Pittsburgh
Investigators
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Principal Investigator: Evan Adelstein, MD University of Pittsburgh
More Information
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Publications of Results:
Connolly SJ, Camm AJ, Halperin JL, Joyner C, Alings M, Amerena J, Atar D, Avezum Á, Blomström P, Borggrefe M, Budaj A, Chen SA, Ching CK, Commerford P, Dans A, Davy JM, Delacrétaz E, Di Pasquale G, Diaz R, Dorian P, Flaker G, Golitsyn S, Gonzalez-Hermosillo A, Granger CB, Heidbüchel H, Kautzner J, Kim JS, Lanas F, Lewis BS, Merino JL, Morillo C, Murin J, Narasimhan C, Paolasso E, Parkhomenko A, Peters NS, Sim KH, Stiles MK, Tanomsup S, Toivonen L, Tomcsányi J, Torp-Pedersen C, Tse HF, Vardas P, Vinereanu D, Xavier D, Zhu J, Zhu JR, Baret-Cormel L, Weinling E, Staiger C, Yusuf S, Chrolavicius S, Afzal R, Hohnloser SH; PALLAS Investigators. Dronedarone in high-risk permanent atrial fibrillation. N Engl J Med. 2011 Dec 15;365(24):2268-76. doi: 10.1056/NEJMoa1109867. Epub 2011 Nov 14. Erratum in: N Engl J Med. 2012 Feb 16;366(7):672.

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Responsible Party: Evan Adelstein, MD, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02575534    
Other Study ID Numbers: PRO14010486
First Posted: October 14, 2015    Key Record Dates
Last Update Posted: June 28, 2018
Last Verified: June 2018
Keywords provided by Evan Adelstein, MD, University of Pittsburgh:
anti-arrhythmic therapy
Additional relevant MeSH terms:
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Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Procainamide
 Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action