The mission of the HESI Cardiovascular Safety Assessment Project Committee is to identify and address scientific issues related to improvement of the scientific basis for cardiovascular safety assessment.

Cardiac repolarization, or QT prolongation, is a potential undesirable outcome from exposure to new and existing therapeutic compounds.  QT prolongation is thought to have a role in the onset of rare cardiac arrhythmias that can lead to sudden death.   The cornerstone of the project committee’s activities is a comprehensive study intended to compare the utility of selected non-clinical approaches for assessing QT prolongation using a panel of drugs with extensive clinical data on their propensity to elicit QT prolongation and proarrhythmia in man.  The scope of the study was to evaluate 12 compounds on test systems designed to detect the risk of QT prolongation by compounds when administered to man.  The specific test systems evaluated included two in vitro assays and an in vivo technique.  The two in vitro assays evaluated were a HERG potassium ion channel assay, and an assay to record action potentials from dog isolated cardiac Purkinje fibers.  The in vivo technique used telemetered dogs to monitor changes in ECG and blood pressure subsequent to exposure to the 12 test compounds. 

Files

To download a copy of the ILSI HESI Cardiovascular Risk Assessment Workshop Proceedings Manuscript, click here.

Download the English Cardiovascular Pro-Arrhythmia Models Project Committee fact sheet here

Download the Japanese Cardiovascular Safety Committee fact sheet here