Comparison of Two Highly Automated ECG Algorithms for Detection of Drug-Induced Cardiac Ion Channel Block.

ABSTRACT: US Food and Drug Administration (FDA) investigators recently demonstrated in a crossover study that early (J-T_peak c) and late (T_peak -T_end ) repolarization duration can differentiate selective potassium block with a high arrhythmia risk from multichannel block with lower risk in subjects receiving dofetilide, verapamil, quinidine, or ranolazine. The purpose of this study was to determine if the findings by the FDA using their published software algorithm could be corroborated using an alternative software algorithm for the same metrics and to determine if methodological differences resulted in clinically meaningful differences in interpretation. Exposure-response relationships computed with linear mixed effects models and mean maximal effects on ECG interv

SUBMITTER: Brockway M 

PROVIDER: S-EPMC5948117 | biostudies-literature | 2018 Aug

REPOSITORIES: biostudies-literature