DESIGN OF A LARGE CROSS-SECTIONAL STUDY TO FACILITATE FUTURE CLINICAL TRIALS IN CHILDREN WITH THE FONTAN PALLIATION

摘要

Background Clinical trials in children with congenital heart disease are often limited by the absence of: 1) a primary outcome that can be observed in a reasonable period of time; 2) information regarding health-related quality of life; 3) knowledge of the correlation between health status and ventricular function and exercise performance; 4) a sufficient number of children at a single institution to provide adequate statistical power; and 5) procedural and management differences between and within institutions.