October 2004

New advances in echocardiography bring increased opportunity and enormous potential to evaluate the cardiac effects of disease and its treatment repetitively and noninvasively in clinical trials. Although many clinical studies have been performed to evaluate echocardiographic techniques per se, these are not the focus of this report. The purpose of this communication is to discuss the utility of echocardiography in enhancing the value of clinical trials by identifying potential mechanisms of clinical end points and determining surrogate end points and to offer recommendations regarding its use. In addition to physicians with expertise in echocardiography, this document is intended for project officers and others working with government or industrial sponsors who may not be familiar with echocardiography but need an in-depth overview of the types of information that can be provided by echocardiography and related techniques in clinical research.