Completed

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

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What is being tested

liothyronine I 131

Drug
Who is being recruted

Congenital Abnormalities+10

+ Cardiovascular Diseases

+ Heart Diseases

Until 17 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: December 1994
See protocol details

Summary

Principal SponsorFDA Office of Orphan Products Development
Last updated: March 25, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 1994

Actual date on which the first participant was enrolled.

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.

NCT00004828
Principal SponsorFDA Office of Orphan Products Development
Last updated: March 25, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

28 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Until 17 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Congenital AbnormalitiesCardiovascular DiseasesHeart DiseasesHeart Valve DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPathologic ProcessesPathological Conditions, Signs and SymptomsCardiovascular AbnormalitiesDisease AttributesHeart Defects, CongenitalRespiratory Tract DiseasesTricuspid AtresiaRare Diseases

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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CompletedNo study centers