Investigation of parameters highlighting drug induced small changes of the T-wave's morphology for drug safety studies

Tobias Baas, Ksenija Gräfe, Antoun Khawaja, Olaf Dössel


In guideline E14, the American Food and Drug Administration (FDA) requests for clinical studies to investigate the prolongation of the heart rate corrected QT-interval (QTc) of the ECG. As drug induced QT-prolongation can be caused by changes in the repolarisation of the ventricles, it is so far a thorough ECG biomarker of risk for ventricular tachyarrhyth-mias and Torsade de Pointes (TdP). Ventricular repolarisation changes not only change QT but also influence the morphology of the T-wave. In a (400 mg single dose) Moxifloxacin positive control study both, QTc and several descriptors describing the T-wave morphology have been measured. Moxifloxacin is changing two shape dependent descriptors significantly (P≤0.05) about 3 to 4 hours after a 400 mg oral single dose of Moxifloxacin.

Original languageGerman
Title of host publicationProceedings of the 33rd IEEE conference on Engineering in Medicine and Biology Society
Publication date2011
ISBN (Print)978-1-4244-4121-1
ISBN (Electronic)978-1-4577-1589-1
Publication statusPublished - 2011
Externally publishedYes

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