The evaluation and management of drug effects on cardiac conduction (PR and QRS Intervals) in clinical development

Adel Nada; Gary A. Gintant; Robert Kleiman; David E. Gutstein; Christer Gottfridsson; Eric L. Michelson; Colette Strnadova; Matthew Killeen; Mary Jane Geiger; Mónica L. Fiszman; Luana Pesco Koplowitz; Glenn F. Carlson; Ignacio Rodriguez; Philip T. Sager

doi:10.1016/j.ahj.2013.01.011

The evaluation and management of drug effects on cardiac conduction (PR and QRS Intervals) in clinical development

Adel Nada
, Gary A. Gintant
, Robert Kleiman
, David E. Gutstein
, Christer Gottfridsson
, Eric L. Michelson
, Colette Strnadova
, Matthew Killeen
, Mary Jane Geiger
, Mónica L. Fiszman
, Luana Pesco Koplowitz
, Glenn F. Carlson
, Ignacio Rodriguez
, Philip T. Sager

Research output: Contribution to journal › Review article › peer-review

44 Scopus citations

Abstract

Recent advances in electrocardiographic monitoring and waveform analysis have significantly improved the ability to detect drug-induced changes in cardiac repolarization manifested as changes in the QT/corrected QT interval. These advances have also improved the ability to detect drug-induced changes in cardiac conduction. This White Paper summarizes current opinion, reached by consensus among experts at the Cardiac Safety Research Consortium, on the assessment of electrocardiogram-based safety measurements of the PR and QRS intervals, representing atrioventricular and ventricular conduction, respectively, during drug development.

Original language	English
Pages (from-to)	489-500
Number of pages	12
Journal	American Heart Journal
Volume	165
Issue number	4
DOIs	https://doi.org/10.1016/j.ahj.2013.01.011
State	Published - Apr 2013
Externally published	Yes

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10.1016/j.ahj.2013.01.011

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Nada, A., Gintant, G. A., Kleiman, R., Gutstein, D. E., Gottfridsson, C., Michelson, E. L., Strnadova, C., Killeen, M., Geiger, M. J., Fiszman, M. L., Koplowitz, L. P., Carlson, G. F., Rodriguez, I., & Sager, P. T. (2013). The evaluation and management of drug effects on cardiac conduction (PR and QRS Intervals) in clinical development. American Heart Journal, 165(4), 489-500. https://doi.org/10.1016/j.ahj.2013.01.011

@article{709f35316f5c4ec9bf3b4c6cfa2cbce7,

title = "The evaluation and management of drug effects on cardiac conduction (PR and QRS Intervals) in clinical development",

abstract = "Recent advances in electrocardiographic monitoring and waveform analysis have significantly improved the ability to detect drug-induced changes in cardiac repolarization manifested as changes in the QT/corrected QT interval. These advances have also improved the ability to detect drug-induced changes in cardiac conduction. This White Paper summarizes current opinion, reached by consensus among experts at the Cardiac Safety Research Consortium, on the assessment of electrocardiogram-based safety measurements of the PR and QRS intervals, representing atrioventricular and ventricular conduction, respectively, during drug development.",

author = "Adel Nada and Gintant, \{Gary A.\} and Robert Kleiman and Gutstein, \{David E.\} and Christer Gottfridsson and Michelson, \{Eric L.\} and Colette Strnadova and Matthew Killeen and Geiger, \{Mary Jane\} and Fiszman, \{M{\'o}nica L.\} and Koplowitz, \{Luana Pesco\} and Carlson, \{Glenn F.\} and Ignacio Rodriguez and Sager, \{Philip T.\}",

year = "2013",

month = apr,

doi = "10.1016/j.ahj.2013.01.011",

language = "English",

volume = "165",

pages = "489--500",

journal = "American Heart Journal",

issn = "0002-8703",

publisher = "Elsevier Inc.",

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}

Nada, A, Gintant, GA, Kleiman, R, Gutstein, DE, Gottfridsson, C, Michelson, EL, Strnadova, C, Killeen, M, Geiger, MJ, Fiszman, ML, Koplowitz, LP, Carlson, GF, Rodriguez, I & Sager, PT 2013, 'The evaluation and management of drug effects on cardiac conduction (PR and QRS Intervals) in clinical development', American Heart Journal, vol. 165, no. 4, pp. 489-500. https://doi.org/10.1016/j.ahj.2013.01.011

TY - JOUR

T1 - The evaluation and management of drug effects on cardiac conduction (PR and QRS Intervals) in clinical development

AU - Nada, Adel

AU - Gintant, Gary A.

AU - Kleiman, Robert

AU - Gutstein, David E.

AU - Gottfridsson, Christer

AU - Michelson, Eric L.

AU - Strnadova, Colette

AU - Killeen, Matthew

AU - Geiger, Mary Jane

AU - Fiszman, Mónica L.

AU - Koplowitz, Luana Pesco

AU - Carlson, Glenn F.

AU - Rodriguez, Ignacio

AU - Sager, Philip T.

PY - 2013/4

Y1 - 2013/4

N2 - Recent advances in electrocardiographic monitoring and waveform analysis have significantly improved the ability to detect drug-induced changes in cardiac repolarization manifested as changes in the QT/corrected QT interval. These advances have also improved the ability to detect drug-induced changes in cardiac conduction. This White Paper summarizes current opinion, reached by consensus among experts at the Cardiac Safety Research Consortium, on the assessment of electrocardiogram-based safety measurements of the PR and QRS intervals, representing atrioventricular and ventricular conduction, respectively, during drug development.

AB - Recent advances in electrocardiographic monitoring and waveform analysis have significantly improved the ability to detect drug-induced changes in cardiac repolarization manifested as changes in the QT/corrected QT interval. These advances have also improved the ability to detect drug-induced changes in cardiac conduction. This White Paper summarizes current opinion, reached by consensus among experts at the Cardiac Safety Research Consortium, on the assessment of electrocardiogram-based safety measurements of the PR and QRS intervals, representing atrioventricular and ventricular conduction, respectively, during drug development.

UR - https://www.scopus.com/pages/publications/84875443952

U2 - 10.1016/j.ahj.2013.01.011

DO - 10.1016/j.ahj.2013.01.011

M3 - Review article

AN - SCOPUS:84875443952

SN - 0002-8703

VL - 165

SP - 489

EP - 500

JO - American Heart Journal

JF - American Heart Journal

IS - 4

ER -

The evaluation and management of drug effects on cardiac conduction (PR and QRS Intervals) in clinical development

Abstract

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