T-wave morphology abnormalities in the STREAM stage 1 trial

Area of Science:

• Cardiology
• Infectious Diseases
• Pharmacology

Background:

• Shorter drug-resistant tuberculosis (DR-TB) regimens offer efficacy but pose risks of QT prolongation.
• T-wave morphology abnormalities on electrocardiograms (ECGs) may serve as early indicators of QT prolongation.

Purpose of the Study:

• To investigate the association between T-wave morphology abnormalities and QT prolongation in patients undergoing DR-TB treatment.
• To evaluate T-wave changes as potential predictors of cardiac adverse events in DR-TB therapy.

Main Methods:

• Analysis of ECG data from the STREAM Stage 1 randomized controlled trial comparing short and long DR-TB regimens.
• Categorization of T-wave morphology (normal vs. abnormal) and assessment of QT/QTcF intervals at baseline, early, and late time points.
• Statistical comparison of T-wave abnormalities and QT prolongation between short and long regimen groups.

Main Results:

• Abnormal T-waves were observed in 23% at baseline, increasing to 45% by the late time point (p < 0.001).
• Short regimens, containing moxifloxacin and clofazimine, were associated with a higher incidence of T-wave abnormalities (64%) compared to long regimens (36.8%, p = 0.003).
• T-wave abnormalities preceded QT/QTcF prolongation (≥500 ms) in 53% of affected participants.

Conclusions:

• T-wave morphology abnormalities are frequent in DR-TB patients and increase over time.
• These T-wave changes may serve as a valuable tool for identifying patients at increased risk of QT prolongation during DR-TB treatment.