Back to resultsLiothyronine in Children With Single Ventricle Congenital Cardiac Malformations Undergoing the Fontan Procedure
Primary Purpose
Tricuspid Atresia, Heart Defects, Congenital
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
liothyronine I 131
Sponsored by
About this trial
This is an interventional treatment trial for Tricuspid Atresia focused on measuring cardiovascular and respiratory diseases, heart defects, rare disease
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
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00004828
First Posted
February 24, 2000
Last Updated
March 24, 2015
Sponsor
FDA Office of Orphan Products Development
Collaborators
Children's Hospital and Health Center
1. Study Identification
Unique Protocol Identification Number
NCT00004828
Brief Title
Liothyronine in Children With Single Ventricle Congenital Cardiac Malformations Undergoing the Fontan Procedure
Study Type
Interventional
2. Study Status
Record Verification Date
June 1998
Overall Recruitment Status
Completed
Study Start Date
December 1994 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 1997 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
FDA Office of Orphan Products Development
Collaborators
Children's Hospital and Health Center
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tricuspid Atresia, Heart Defects, Congenital
Keywords
cardiovascular and respiratory diseases, heart defects, rare disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Allocation
Randomized
Enrollment
28 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
liothyronine I 131
10. Eligibility
Sex
All
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Mainwaring
Organizational Affiliation
Children's Hospital and Health Center
Official's Role
Study Chair
12. IPD Sharing Statement
Learn more about this trial
Liothyronine in Children With Single Ventricle Congenital Cardiac Malformations Undergoing the Fontan Procedure
We'll reach out to this number within 24 hrs