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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00004828
First Posted: February 25, 2000
Last Update Posted: March 25, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Children's Hospital and Health Center
Information provided by:
FDA Office of Orphan Products Development
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00004828     History of Changes
Other Study ID Numbers: 199/13357
CHSD-585
CHSD-FDR001195
First Submitted: February 24, 2000
First Posted: February 25, 2000
Last Update Posted: March 25, 2015
Last Verified: June 1998

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