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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 7 April 2015
Main ID:  NCT00004828
Date of registration: 24/02/2000
Prospective Registration: No
Primary sponsor: FDA Office of Orphan Products Development
Public title: Liothyronine in Children With Single Ventricle Congenital Cardiac Malformations Undergoing the Fontan Procedure
Scientific title:
Date of first enrolment: December 1994
Target sample size: 28
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT00004828
Study type:  Interventional
Study design:  Allocation: Randomized, Primary Purpose: Treatment  
Phase:  Phase 1
Countries of recruitment
Contacts
Name:     Richard Mainwaring
Address: 
Telephone:
Email:
Affiliation:  Children's Hospital and Health Center
Key inclusion & exclusion 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



Age minimum: N/A
Age maximum: 17 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Tricuspid Atresia
Heart Defects, Congenital
Intervention(s)
Drug: liothyronine I 131
Primary Outcome(s)
Secondary Outcome(s)
Secondary ID(s)
CHSD-585
199/13357
CHSD-FDR001195
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Children's Hospital and Health Center
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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