02699nas a2200409 4500000000100000008004100001260001200042653004500054653001600099653002200115653001300137653001600150653001600166100001500182700001500197700001500212700001200227700001200239700001100251700001500262700001500277700001100292700001600303700001500319700001600334700001500350700002500365700001300390700001900403700001400422245012900436856006900565300000800634490000700642520162600649022001402275 2024 d c08/202410amobile QT interval monitoring strategies10aFeasibility10aleprosy treatment10aaccuracy10aBedaquiline10aProphylaxis1 aBergeman A1 aNourdine S1 aPiubello A1 aSalim Z1 aBraet S1 aBaco A1 aGrillone S1 aSnijders R1 aHoof C1 aTsoumanis A1 avan Loen H1 aAssoumani Y1 aMzembaba A1 aOrtuño-Gutiérrez N1 aHasker E1 avan der Werf C1 ade Jong B00aFeasibility and accuracy of mobile QT interval monitoring strategies in bedaquiline-enhanced prophylactic leprosy treatment. uhttps://ascpt.onlinelibrary.wiley.com/doi/epdf/10.1111/cts.13861 a1-70 v173 a
Some anti-mycobacterial drugs are known to cause QT interval prolongation, potentially leading to life-threatening ventricular arrhythmia. However, the highest leprosy and tuberculosis burden occurs in settings where electrocardiographic monitoring is challenging. The feasibility and accuracy of alternative strategies, such as the use of automated measurements or a mobile electrocardiogram (mECG) device, have not been evaluated in this context. As part of the phase II randomized controlled BE-PEOPLE trial evaluating the safety of bedaquiline-enhanced post-exposure prophylaxis (bedaquiline and rifampicin, BE-PEP, versus rifampicin, SDR-PEP) for leprosy, all participants had corrected QT intervals (QTc) measured at baseline and on the day after receiving post-exposure prophylaxis. The accuracy of mECG measurements as well as automated 12L-ECG measurements was evaluated. In total, 635 mECGs from 323 participants were recorded, 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 absolute QTc difference between both modalities was 11 ± 10 ms. Mean manual and automated 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 mECG device for QT interval monitoring was feasible and yielded a median absolute QTc error of 8 ms. Automated QTc measurements were less accurate, yielding longer QTc intervals.
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