T. Baas, K. Gräfe, A. Khawaja, and O. Dössel. Investigation of parameters highlighting drug induced small changes of the T-wave's morphology for drug safety studies. In Conf Proc IEEE Eng Med Biol Soc, pp. 3796-3799, 2011
Abstract:
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 tachyarrhythmias 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.
Student Theses (1)
K. Gräfe. Untersuchung des Einflusses von Moxifloxacin auf die Morphologie des EKG-Signals zur Verbesserung der QT-Analyse. Institut für Biomedizinische Technik, Karlsruher Institut für Technologie (KIT). Masterarbeit. 2011