QT study

A clinical study to assess the potential of a drug to affect heart rhythms.

Some drugs, including some antibiotics, can lengthen the time it takes for the heart muscles to prepare for contraction, known as prolongation of the QT interval. The QT interval is a measurement made on an electrocardiogram. Because of this risk, regulatory authorities require that drug developers provide evidence of their drug’s impact on the QT interval.

Guidance for Industry: E14 Clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs (FDA, 2005)

ICH Topic E 14 The clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs (EMA, 2005)

New approaches for an integrated nonclinical-clinical QT/Proarrhythmic risk assessment (1 of 2) (FDA, 2020)