Acute Mechanical Response to Anti-arrhythmic Drug Therapy

Arrhythmias Clinical Trial

— AAD and CRT  

Official title:

Acute Mechanical Response to Anti-arrhythmic Drug Therapy

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02575534
• Other study ID #: PRO14010486
• Status: Withdrawn
• Phase: N/A
• Start date: October 2015
• Est. completion date: February 27, 2018

Study information

• Verified date: June 2018
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 27, 2018
• Est. primary completion date: February 27, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Arrhythmias

Intervention

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

Locations

Country	Name	City	State
United States	Evan Adelstein	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Evan Adelstein, MD	University of Pittsburgh

Country where clinical trial is conducted

United States, 

References & Publications (7)

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 Investigat — View 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. — View Citation

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-Hermosil — View Citation

Connolly SJ, Dorian P, Roberts RS, Gent M, Bailin S, Fain ES, Thorpe K, Champagne J, Talajic M, Coutu B, Gronefeld GC, Hohnloser SH; Optimal Pharmacological Therapy in Cardioverter Defibrillator Patients (OPTIC) Investigators. Comparison of beta-blockers, — View 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 — View 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 T — View 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, amiod — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in QRS duration	the QRS waveform measurements will be calculated on the EKG prior to and after the procainamide infusion	baseline and 1 hour post infusion
Primary	changes in left ventricular volumes as measured via echocardiogram	the left ventricular volume will be calculated via echocardiogram pre and post procainamide infusion	baseline and 1 hour post infusion
Primary	changes in ejection fraction as measured via echocardiogram	ejection fraction will be calculated via echocardiogram pre and post procainamide infusion.	baseline and 1hour post infusion
Primary	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.	baseline and 1 hour post infusion