Arrhythmias
Conditions
Keywords
anti-arrhythmic therapy
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.
Interventions
DRUGProcainamide
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
Sponsors
University of Pittsburgh
Evan Adelstein, MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in QRS duration | baseline and 1 hour post infusion | 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 | baseline and 1 hour post infusion | the left ventricular volume will be calculated via echocardiogram pre and post procainamide infusion |
| changes in ejection fraction as measured via echocardiogram | baseline and 1hour post infusion | ejection fraction will be calculated via echocardiogram pre and post procainamide infusion. |
| changes in RV-LV electrical activation (in CRT patients) | baseline and 1 hour post infusion | The RV-LV electrical activation will be assessed during the device interrogation pre and post procainamide infusion. |
Countries
United States
Outcome results
None listed