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Late Sodium Current Blockade in High-Risk ICD Patients (RAID)
Primary aim of the study is:
To determine whether ranolazine administration will decrease the likelihood of a composite arrhythmia endpoint consisting of ventricular tachycardia or ventricular fibrillation (VT/VF) requiring antitachycardia pacing (ATP), ICD shocks, or death;
In addition to the above primary specific aim, there are several secondary aims that will be addressed in this trial by utilizing data from detailed records of arrhythmia episodes provided by implanted devices, and comprehensive data on hospitalizations during follow-up.
Specific secondary aims are as follows:
1. to determine whether ranolazine administration will decrease the likelihood of a composite arrhythmia endpoint consisting of VT or VF requiring ICD shock or death (while excluding VT/VF requiring just ATP)
2. to determine whether ranolazine administration will decrease the likelihood of composite primary endpoints consisting of hospitalization for cardiac causes (including not only hospitalization for heart failure, but also hospitalizations related to cardiac arrhythmias, myocardial infarction or ischemia) or death, whichever occurs first.
3. to determine whether ranolazine administration will decrease the likelihood of a composite secondary endpoint consisting of CHF hospitalization or death;
4. to determine whether ranolazine therapy will decrease the number of repeated hospitalizations for cardiac causes.
5. to determine whether ranolazine administration will decrease the likelihood of repeated ICD therapies (not just first therapy)
6. to determine whether ranolazine administration will decrease the likelihood of inappropriate shocks (a decrease in episodes of atrial fibrillation triggering inappropriate therapy) evaluating the risk of first and risk of repeated inappropriate shocks.
7. to determine whether ranolazine therapy will be associated with improvement in exercise capacity measured by the 6-minute walk test (6MWT) and in the quality of life measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)
8. to evaluate the safety of ranolazine therapy utilizing ICD interrogation data documenting all types of ventricular tachyarrhythmias (including torsade de pointes).
Primary aim of the study is:
To determine whether ranolazine administration will decrease the likelihood of a composite arrhythmia endpoint consisting of ventricular tachycardia or ventricular fibrillation (VT/VF) requiring antitachycardia pacing (ATP), ICD shocks, or death;
In addition to the above primary specific aim, there are several secondary aims that will be addressed in this trial by utilizing data from detailed records of arrhythmia episodes provided by implanted devices, and comprehensive data on hospitalizations during follow-up.
Specific secondary aims are as follows:
1. to determine whether ranolazine administration will decrease the likelihood of a composite arrhythmia endpoint consisting of VT or VF requiring ICD shock or death (while excluding VT/VF requiring just ATP)
2. to determine whether ranolazine administration will decrease the likelihood of composite primary endpoints consisting of hospitalization for cardiac causes (including not only hospitalization for heart failure, but also hospitalizations related to cardiac arrhythmias, myocardial infarction or ischemia) or death, whichever occurs first.
3. to determine whether ranolazine administration will decrease the likelihood of a composite secondary endpoint consisting of CHF hospitalization or death;
4. to determine whether ranolazine therapy will decrease the number of repeated hospitalizations for cardiac causes.
5. to determine whether ranolazine administration will decrease the likelihood of repeated ICD therapies (not just first therapy)
6. to determine whether ranolazine administration will decrease the likelihood of inappropriate shocks (a decrease in episodes of atrial fibrillation triggering inappropriate therapy) evaluating the risk of first and risk of repeated inappropriate shocks.
7. to determine whether ranolazine therapy will be associated with improvement in exercise capacity measured by the 6-minute walk test (6MWT) and in the quality of life measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)
8. to evaluate the safety of ranolazine therapy utilizing ICD interrogation data documenting all types of ventricular tachyarrhythmias (including torsade de pointes).
Recruitment Status
Past Studies