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

This study has been completed.

First Received: February 24, 2000 Last Updated: June 23, 2005 History of Changes

Sponsors and Collaborators:	FDA Office of Orphan Products Development Children's Hospital and Health Center
Information provided by:	FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:	NCT00004828

Purpose

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.

Condition	Intervention	Phase
Tricuspid Atresia Heart Defects, Congenital	Drug: liothyronine I 131	Phase I

MedlinePlus related topics: Congenital Heart Defects

Drug Information available for: Liothyronine sodium Liothyronine I 131 Triiodothyronine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Placebo Control

Further study details as provided by FDA Office of Orphan Products Development:

Estimated Enrollment:	28
Study Start Date:	December 1994
Estimated Study Completion Date:	December 1997

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

Ages Eligible for Study:	up to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004828

Sponsors and Collaborators

FDA Office of Orphan Products Development

Children's Hospital and Health Center

Investigators

Study Chair:

Richard Mainwaring

Children's Hospital and Health Center

More Information

No publications provided

Study ID Numbers:	199/13357, CHSD-585, CHSD-FDR001195
Study First Received:	February 24, 2000
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004828 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by FDA Office of Orphan Products Development:

cardiovascular and respiratory diseases
heart defects
rare disease

Study placed in the following topic categories:

Single Ventricular Heart
Heart Diseases
Tricuspid Atresia
Cardiovascular Abnormalities
Respiration Disorders

Rare Diseases
Congenital Abnormalities
Heart Defects, Congenital
Heart Valve Diseases

Additional relevant MeSH terms:

Heart Diseases
Tricuspid Atresia
Cardiovascular Abnormalities
Cardiovascular Diseases

Congenital Abnormalities
Heart Defects, Congenital
Heart Valve Diseases

ClinicalTrials.gov processed this record on May 07, 2009