Reliability of ventricular remodeling as a surrogate for use in conjunction with clinical outcomes in heart failure

Abstract

As the number of treatments for heart failure (HF) increases and mortality decreases in the setting of clinical trials, the size of the study population required to demonstrate an incremental difference in survival with each new agent may become prohibitive. There has been increasing interest in identifying and validating surrogate end points for assessing HF treatments. The strong association between ventricular remodeling and clinical outcomes supports the incorporation of measures of ventricular volumes into clinical trials of new therapies for HF. A finding of reduced left ventricular volumes renders a particular survival signal more credible. It is therefore appropriate to consider ventricular remodeling in conjunction with outcome events in the construct of clinical trials in HF.