Highly-Automated Analysis of QTcI/QTcF in Thorough QT (TQT) Study

Time

Wed, Jun 26 11:45AM
W 02

Title

Highly-Automated Analysis of QTcI/QTcF in Thorough QT (TQT) Study

Abstract Summary

Methods Data are derived from a study, in which 47 healthy volunteers (20 males, mean age 29.9 years, body mass index 18-30) were randomized in a cross-over design to four treatment periods: placebo, two doses of an active compound and positive control (400 mg Moxifloxacin single dose). Baseline 24-hour heart rate was recorded to meet recent guidelines for drugs which potentially modifying heart rate. Twelve-lead Holter was recorded during all five periods with an H12+ recording (Mortara Instruments, WI). For each baseline recording, one 10-second ECG was extracted every 5 minutes over a period of 12 hours using an automated tool that optimizes the selection of the ECG on the basis of signal noise and heart rate stability (Antares 2.8.0, AMPS-LLC, NY). These baseline-extracted ECGs were then used to determine the subject-specific QTcI individual correction index (power-law model). For each of the four on-drug periods, 10 second ECG triplicates were extracted using the same algorithm used for baseline. Two separate sets of extraction timepoints were generated: the first corresponded to strictly controlled time segments when study subjects were to remain in the supine position, whereas the second set was chosen with each timepoint shifted by 4 minutes for 0-1 hour timepoints, shifted by 30 minutes for 1-6 hours timepoints, and by 1.5 hours for 8.5-23 hour timeponts, so that the ECGs selected could fall outside the strictly controlled time windows (and with subjects no longer in the supine position).

Poster Presenter

Pierre Maison-Blanche
Chief Medical Officer,
Cardiabase
France

© 2015 DIA