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

Information source: FDA Office of Orphan Products Development
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Tricuspid Atresia; Heart Defects, Congenital

Intervention: liothyronine I 131 (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: FDA Office of Orphan Products Development

Official(s) and/or principal investigator(s):
Richard Mainwaring, Study Chair, Affiliation: Children's Hospital and Health Center

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.

Clinical Details

Study design: Allocation: Randomized, Primary Purpose: Treatment

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.

Eligibility

Minimum age: N/A. Maximum age: 17 Years. Gender(s): Both.

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

Locations and Contacts

Additional Information

Starting date: December 1994
Last updated: March 24, 2015

Page last updated: August 23, 2015

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