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

Brief Title

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


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 Phase

Phase 1

Study Type

Interventional




Condition

Tricuspid Atresia

Intervention

liothyronine I 131


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

28

Start Date

December 1994

Completion Date

December 1997


Eligibility 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
      

Gender

All

Ages

N/A - 17 Years

Accepts Healthy Volunteers

No

Contacts

Richard Mainwaring, , 



Administrative Informations


NCT ID

NCT00004828

Organization ID

199/13357

Secondary IDs

CHSD-585


Study Sponsor

FDA Office of Orphan Products Development

Collaborators

 Children's Hospital and Health Center

Study Sponsor

Richard Mainwaring, Study Chair, Children's Hospital and Health Center


Verification Date

June 1998