NCT00004828

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (planned)
• Sponsor: FDA Office of Orphan Products Development · Federal
• Sex: All
• Age: 17 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PROTOCOL OUTLINE: This is a randomized, placebo controlled, dose escalation study. Initially, patients are randomized to receive either 1 of 3 different dosages of liothyronine or placebo after undergoing the Fontan procedure. If no unacceptable toxicity is observed in this group, a third dose level of liothyronine is added to the randomization. A total of 7 patients are enrolled at each dose level. All randomized study drugs are administered by continuous infusion over 1 hour after surgery. Cardiac function is assessed 5 days after surgery.

Conditions

• Tricuspid Atresia
• Heart Defects, Congenital

Interventions

Type	Name	Description
DRUG	liothyronine I 131

Timeline

• Start date: 1994-12-01
• Completion: 1997-12-01
• First posted: 2000-02-25
• Last updated: 2015-03-25