Heart Failure Clinical Trial
Official title:
Late Sodium Current Blockade in High-Risk ICD Patients
The purpose of the study is to see how effective a drug called ranolazine is in reducing the risk of ventricular arrhythmia and death in people with implantable cardioverter-defibrillators (ICDs). This drug will be used with standard medications that is routinely prescribed in enrolled patients.
There are limited treatment options for patients at high risk of ventricular arrhythmic
events. Beta-blockers alone do not provide enough protection, sotalol has limited
effectiveness, and amiodarone although effective in some groups of patients is used
infrequently due to its side effects and limitations of a long-term use. Ischemia and
cardiomyopathies are associated with a sodium overload of myocardial cells. Late sodium
current plays a pivotal role in this process. Sodium overload leads to calcium overload of
myocardial cells with consequent increased vulnerability of myocardium to ventricular
tachyarrhythmias as well as increased impairment of diastolic relaxation of myocardium
thereby augmenting the risk of ischemia and myocardial damage.
Ranolazine is a novel drug with anti-ischemic and antiarrhythmic properties that uniquely
blocks late sodium current, decreases intracellular calcium overload, and improves diastolic
relaxation of the ventricles. The antiischemic and antiarrhythmic properties of ranolazine
might decrease the likelihood of arrhythmic events and improve the clinical course of
patients with ventricular arrhythmias.
We designed a randomized double-blind placebo-controlled clinical trial enrolling 1,440
high-risk ICD patients who will be treated with ranolazine or placebo in addition to optimal
medical therapy to test the hypothesis that late sodium current blockade contributes to
significant reduction in the risk of arrhythmic events or death in high-risk ICD/cardiac
resynchronization therapy-D patients.
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