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Clinical Trials/NCT00004828
NCT00004828CompletedPhase 1

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

FDA Office of Orphan Products Development0 sites28 target enrollmentStarted: December 1, 1994Last updated:
Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Sponsor
Enrollment
28

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Primary Purpose
Treatment

Eligibility Criteria

Ages
— to 17 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion 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

Exclusion Criteria

  • Not provided

Investigators

Sponsor
FDA Office of Orphan Products Development
Sponsor Class
Fed

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