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, 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 alt...

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Veröffentlicht in:Clinical and translational science Jg. 17; H. 8; S. e13861 - n/a
Hauptverfasser: Bergeman, Auke T., Nourdine, Said, Piubello, Alberto, Salim, Zahara, Braet, Sofie M., Baco, Abdallah, Grillone, Silahi H., Snijders, Rian, Hoof, Carolien, Tsoumanis, Achilleas, Loen, Harry, Assoumani, Younoussa, Mzembaba, Aboubacar, Ortuño‐Gutiérrez, Nimer, Hasker, Epco, Werf, Christian, Jong, Bouke C.
Format: Journal Article
Sprache:Englisch
Veröffentlicht: United States John Wiley & Sons, Inc 01.08.2024
John Wiley and Sons Inc
Wiley
Schlagworte:
Accuracy
Adult
Arrhythmia
Automation
Diarylquinolines - administration & dosage
Diarylquinolines - adverse effects
Disease prevention
Drug dosages
Drug Therapy, Combination - methods
EKG
Electrocardiography
Ethics
Feasibility Studies
Female
Heart rate
Humans
Leprostatic Agents - administration & dosage
Leprostatic Agents - adverse effects
Leprosy
Leprosy - diagnosis
Leprosy - drug therapy
Long QT Syndrome - chemically induced
Long QT Syndrome - diagnosis
Male
Middle Aged
Performance evaluation
Prophylaxis
Rifampin
Rifampin - administration & dosage
Rifampin - adverse effects
Young Adult
Comoro Islands
ISSN:1752-8054, 1752-8062, 1752-8062
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Zusammenfassung: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.
Bibliographie:ObjectType-Article-1
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ISSN:1752-8054
1752-8062
1752-8062
DOI:10.1111/cts.13861