CompletedPhase 1

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

28 participantsStarted 1994-12

Plain-language 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.

Who can participate

Age range17 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* 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

Trial details

NCT IDNCT00004828

SponsorFDA Office of Orphan Products Development

Sponsor typeFED

Study typeINTERVENTIONAL

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