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

This study has been completed.
Sponsor:
Collaborator:
Children's Hospital and Health Center
Information provided by:
FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:
NCT00004828
First received: February 24, 2000
Last updated: June 23, 2005
Last verified: June 1998
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
Children's Hospital and Health Center
Investigators
Study Chair: Richard Mainwaring Children's Hospital and Health Center
  More Information

No publications provided

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

Keywords provided by FDA Office of Orphan Products Development:
cardiovascular and respiratory diseases
heart defects
rare disease

Additional relevant MeSH terms:
Congenital Abnormalities
Heart Defects, Congenital
Tricuspid Atresia
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Heart Valve Diseases

ClinicalTrials.gov processed this record on September 18, 2014