NCT00004828

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 1994

Typical duration for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 1994

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 1997

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

February 24, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 25, 2000

Completed
Last Updated

March 25, 2015

Status Verified

June 1, 1998

First QC Date

February 24, 2000

Last Update Submit

March 24, 2015

Conditions

Tricuspid AtresiaHeart Defects, Congenital

Keywords

cardiovascular and respiratory diseasesheart defectsrare disease

Interventions

liothyronine I 131DRUG

Eligibility Criteria

AgeUp to 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
* 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Tricuspid AtresiaHeart Defects, CongenitalRespiratory Tract DiseasesRare Diseases

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesHeart Valve DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Richard Mainwaring

    Children's Hospital and Health Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
FED

Study Record Dates

First Submitted

February 24, 2000

First Posted

February 25, 2000

Study Start

December 1, 1994

Study Completion

December 1, 1997

Last Updated

March 25, 2015

Record last verified: 1998-06