Overview

Liothyronine in Children With Single Ventricle Congenital Cardiac Malformations Undergoing the Fontan Procedure

Status:
Completed
Trial end date:
1997-12-01
Target enrollment:
Participant gender:
Summary
OBJECTIVES: I. Determine the pharmacokinetics of exogenous liothyronine administered in children undergoing the modified Fontan procedure. II. Determine the liothyronine supplementation dose that counters the fall in serum liothyronine concentrations and provides the greatest potential myocardial benefit after the modified Fontan procedure. III. Evaluate the potential toxicity of exogenous liothyronine administered in children undergoing a modified Fontan procedure.
Phase:
Phase 1
Details
Lead Sponsor:
FDA Office of Orphan Products Development
Collaborator:
Children's Hospital and Health Center