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

Heart Defects, Congenital Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004828
• Other study ID #: 199/13357
• Secondary ID: CHSD-585CHSD-FDR
• Status: Completed
• Phase: Phase 1
• First received: February 24, 2000
• Last updated: March 24, 2015
• Start date: December 1994
• Est. completion date: December 1997

Study information

• Verified date: June 1998
• Source: FDA Office of Orphan Products Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: December 1997
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 17 Years

Eligibility

• 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

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Congenital Abnormalities
• Heart Defects, Congenital
• Tricuspid Atresia

Intervention

Drug:
• liothyronine I 131

Locations

Country	Name	City	State
n/a

Sponsors (2)

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