Evaluating pathophysiologic processes rather than clinical end points in improving therapeutic practice.

Abstract

Cardiovascular clinical trials and clinical practice are currently aimed at reducing morbidity and mortality, but a more efficient and effective guide to therapeutic efficacy would be surrogate markers that track the progression of disease that precipitates clinical end points. Structural alterations of the left ventricle and abnormalities of endothelial function that lead to functional and structural alterations of the vasculature are the best candidates for useful surrogate markers. Methods for quantitating these functional and structural alterations must be validated to provide documentation of their sensitivity and specificity.