ESCAPE Mechanistic Substudies - Ancillary to ESCAPE

BACKGROUND:

The study will develop easily obtained surrogate markers to be incorporated into a model that can function in place of "hard" end-points in the assessment of new treatments in patients with heart failure. In view of the epidemiologic importance of heart failure and the large and expensive studies currently required to test new treatments, a successful surrogate marker model would be a major advance in this field that would both speed the development and reduce the cost of therapeutic advances.

The study is ancillary to the NHLBI-supported clinical trial "Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness (ESCAPE)." ESCAPE compares the efficacy of Pulmonary Artery Catheterization (PAC)-directed treatment strategy to a non-invasive treatment strategy on morbidity and mortality in patients with severe, class IV New York Heart Association (NYHA) congestive heart failure. A secondary objective of ESCAPE is to determine costs and resource utilization of PAC-directed treatment strategy compared to non-invasive treatment strategy.

The study is in response to an initiative "Ancillary Studies in Heart, Lung, and Blood Disease Trials" released by the National Heart, Lung, and Blood Institute in June 2000.

DESIGN NARRATIVE: