SHIELD-2 Trial

The Efficacy and Safety Study of Azimilide on the Incidence of CV Hospitalizations/ED Visits or CV Death in Patients with an ICD trial assessed the effect of azimilide on CV death or hospitalization in patients with an implantable cardioverter defibrillator and reduced left ventricular ejection fraction.

Design: Randomized, double blind, parallel assignment

Patients: 240

Centers: 138

Countries: 12

Results: The study was prematurely discontinued due to withdrawal of sponsorship. The azimilide group had numerical but not statistically significant reductions in the primary outcome of time to first unplanned CV hospitalization, CV ED visit or CV death (OR = 0.79; 95% CI, 0.44-1.44), unplanned CV hospitalization (OR = 0.75; 95% CI, 0.41-1.38), ED visits (OR = 0.68; 95% CI, 0.35-1.31) and all-cause shocks (OR = 0.58; 95% CI, 0.32-1.05). There were fewer adverse events in the azimilide group.

Original Publications:
Robinson VM, et al. Am Heart J. 2016;doi:10.1016/j.ahj.2016.10.025.