Clinical trial NCT02575534: Acute Mechanical Response to Anti-arrhythmic Drug Therapy
Official title: Acute Mechanical Response to Anti-arrhythmic Drug Therapy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Arrhythmias
Keywords: anti-arrhythmic therapy
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: University of Pittsburgh
First posted: 2015-10-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Change in QRS duration
timeFrame: baseline and 1 hour post infusion
measure: changes in left ventricular volumes as measured via echocardiogram
timeFrame: baseline and 1 hour post infusion
measure: changes in ejection fraction as measured via echocardiogram
timeFrame: baseline and 1hour post infusion
measure: changes in RV-LV electrical activation (in CRT patients)
timeFrame: baseline and 1 hour post infusion
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Evan Adelstein
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Evan Adelstein, MD
role: PRINCIPAL_INVESTIGATOR
References:
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