blue U.S. Food & Drug Administration (FDA)
green European Medicines Agency (EMA)
Some therapies can cause cardiac hypertrophy leading to left ventricular systolic dysfunction and possibly heart failure. These drug-induced changes are most commonly monitored in patients utilizing echocardiography (imaging), and more recently, natriuretic peptides (NPs), cardiac hormones synthesized and secreted in response to myofiber stretch. The non-invasive, rapid, and inexpensive nature of NP measurements make them attractive candidates for both nonclinical species and patients. PSTC is investigating whether NT-proANP, the active, cleaved form of atrial NP, is an appropriate marker for measurement of drug-induced changes in heart weight and decreased ejection fraction that, when elevated in nonclinical safety studies, could trigger utilization of clinical BNP measurements to monitor drug-induced hemodynamic stress leading to decreased ejection fraction and/or cardiac hypertrophy. This work will protect patients from potentially serious cardiac side-effects from therapeutic treatment.