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

NCT00004828 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2015-03-25

No results posted yet for this study

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.

Conditions

  • Tricuspid Atresia
  • Heart Defects, Congenital

Interventions

DRUG

liothyronine I 131

Sponsors & Collaborators

  • Children's Hospital and Health Center

    collaborator OTHER

  • FDA Office of Orphan Products Development

    lead FED

Principal Investigators

  • Richard Mainwaring · Children's Hospital and Health Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT

Eligibility

Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1994-12-31
Completion
1997-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00004828 on ClinicalTrials.gov