Feasibility and accuracy of mobile QT interval monitoring strategies in bedaquiline-enhanced prophylactic leprosy treatment

Some anti- mycobacterial drugs are known to cause QT interval prolongation, po-tentially leading to life-threatening ventricular arrhythmia. However, the highestleprosy and tuberculosis burden occurs in settings where electrocardiographicmonitoring is challenging. The feasibility and accuracy of alternative strate-gies, such as the use of automated measurements or a mobile electrocardiogram(mECG) device, have not been evaluated in this context. As part of the phaseII randomized controlled BE-PEOPLE trial evaluating the safety of bedaquiline-enhanced post-exposure prophylaxis (bedaquiline and rifampicin, BE- PEP, ver-sus rifampicin, SDR-PEP) for leprosy, all participants had corrected QT intervals(QTc) measured at baseline and on the day after receiving post-exposure proph-ylaxis. The accuracy of mECG measurements as well as automated 12L-ECGmeasurements was evaluated. In total, 635 mECGs from 323 participants wererecorded, of which 616 (97%) were of sufficient quality for QTc measurement.Mean manually read QTc on 12L-ECG and mECG were 394 ± 19 and 385 ± 18 ms,respectively (p < 0.001), with a strong correlation (r = 0.793). The mean abso-lute QTc difference between both modalities was 11 ± 10 ms. Mean manual andautomated 12L-ECG QTc were 394 ± 19 and 409 ± 19 ms, respectively (n = 636;p < 0.001), corresponding to moderate agreement (r = 0.655). The use of a mECGdevice for QT interval monitoring was feasible and yielded a median absoluteQTc error of 8 ms. Automated QTc measurements were less accurate, yieldinglonger QTc intervals.