URMC, FDA to collaborate on national data repository for heart research

"The opportunity to interact with Dr. Couderc and the University of Rochester is important for at least two reasons," said Norman Stockbridge, M.D., director of FDA's Division of Cardiovascular and Renal Products. "First, they are accumulating unique data that will be useful in understanding how certain cardiac risks can be revealed by specific changes seen on the electrocardiogram. Second, Dr. Couderc and his colleagues bring valuable expertise in identifying properties of the ECG tracing that reveal whether a drug is causing a specific side effect, or that reveal a patient's susceptibility to dangerous heart arrhythmias."

Sudden cardiac arrest is the leading cause of death in the United States, resulting in over 450,000 deaths per year. One mechanism of cardiovascular death is related to drugs triggering a predisposition to lethal cardiac arrhythmias or by the drugs themselves. As part of FDA's regulatory review, the agency requires evidence of a drug's impact on the QT interval as one way to assess the cardiac risk associated with new compounds. The QT interval is a segment of an ECG recording that measures the process of ventricular repolarization – the period between the heart's contraction and recovery phase. If a drug prolongs the repolarization process, then it is generally believed to heighten the risk for adverse cardiac events. Prolongation of the QT interval associated with episodes of fatal ventricular arrhythmias is a leading cause of removal of drugs from the market and was a leading impetus toward international collaboration to develop specialized studies to monitor the QT prolongation effects of new drugs

The THEW will be housed at URMC's Heart Research Follow-up Program. The program is anticipated to be an international effort in the science of heart arrhythmias and a rare genetic condition associated with an abnormal QT interval, called the congenital Long QT Syndrome (LQTS). The university keeps an International Registry for LQTS, and follows thousands of families who have this inherited condition. One of the genetic forms of the QT prolongation syndrome is similar to the drug-induced syndrome, and the university's work focuses on developing the tools to identify individuals with either condition.

THEW website: http://www.thew-project.org/