Completed PHASE1 INTERVENTIONAL NCT00004828

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

Sponsor: Children's Hospital and Health Center

Conditions Heart Defects, Congenital Tricuspid Atresia

Updated 5 times since 2017 Last updated: Mar 24, 2015 Started: Dec 31, 1994 Completion: Dec 31, 1997

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE1 clinical study on Heart Defects, Congenital and Tricuspid Atresia, this trial is completed. The trial is conducted by Children's Hospital and Health Center and has accumulated 5 data snapshots since 1994. Cardiovascular trials of this type often inform treatment guidelines for long-term patient management.

Study Description(click to expand)

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.

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.

Status Flow

Change History

5 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE1
Jul 2024 — Sep 2024 [monthly]

Completed PHASE1
Jan 2021 — Jul 2024 [monthly]

Completed PHASE1
Jun 2018 — Jan 2021 [monthly]

Completed PHASE1
Jan 2017 — Jun 2018 [monthly]

Completed PHASE1

First recorded

Dec 1994

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Children's Hospital and Health Center
FDA Office of Orphan Products Development

Data source: FDA Office of Orphan Products Development

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

No location information available.