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

• Status: Completed
• Trial end date: 1997-12-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: FDA Office of Orphan Products Development
• Collaborator: Children's Hospital and Health Center

Criteria

• Single ventricle congenital cardiac malformation

• Must undergo modified Fontan procedure

• No concurrent medications known to interfere with thyroid metabolism including propranolol and amiodarone

• No hepatic dysfunction

• No renal dysfunction

• No pre-existing thyroid dysfunction