Acute Mechanical Response to Anti-arrhythmic Drug Therapy
| Status: | Withdrawn |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 85 |
| Updated: | 6/30/2018 |
| Start Date: | October 2015 |
| End Date: | February 27, 2018 |
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.
mechanism exert a detrimental electromechanical effect on cardiac function in patients
depending upon baseline intraventricular conduction and left ventricular function.
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.
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.
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)
We found this trial at
1
site
Click here to add this to my saved trials
