Official Title: “Randomized Prospective Study of T3 on the Incidence of Post-Operative Atrial Fibrillation in Patients Undergoing Cardiac Surgery”

The purpose of this project is to see whether treatment with a thyroid hormone, called triiodothyronine or T3, following open heart surgery reduces the risk of developing atrial fibrillation.

Study Type: Interventional

Study Design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Efficacy Study

Study Primary Completion Date: August 2006

Intervention(s) in this Clinical Trial

• Drug: Triiodothyronine
  • 0.8 mcg/kg bolus loading dose followed by a six hour infusion of 0.8 mcg/kg/6hr.
• Drug: triiodothyronine
  • IV formulation - Triostat, 0.8 mcg/kg bolus loading dose followed by a six hour infusion of 0.8 mcg/kg/6hr.

Primary Measures

• incidence of atrial fibrillation
  • Time Frame: during hospitalization
    Safety Issue?: No

Inclusion Criteria:

• 1. Patients requiring CABG or valve repair/replacement surgery.
• 2. Patient must be able to provide informed consent.

Exclusion Criteria:

• 1. Patients less than 18 or over 85 years of age.
• 2. Patients less than 50kg or greater than 120kg.
• 3. Patients currently with endocrine disorders, excluding diabetes.
• 4. Patients currently with thyroid dysfunction (e.g., hyper- hyperthyroidism, goiter, Grave's disease), myxedema, or myxedema coma, even if treated.
• 5. Patients currently receiving thyroid replacement therapy.
• 6. Patients currently receiving Ketamine, levarterenol or dietary (non-food) iodine supplementation.
• 7. Patients who have received any investigational drugs within the previous one month or five half-lives of the drug.
• 8. Patients who are pregnant. Pregnancy testing will be done for women of child-bearing potential.
• 9. Patients currently in atrial fibrillation.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 85 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: North Shore Long Island Jewish Health System

Overall Clinical Trial Officials and Contacts

Irwin Klein, MD Principal Investigator North Shore University Hospital  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00289367

Study ID Number: 05-075

ClinicalTrials.gov Identifier: NCT00289367

Health Authority: United States: Food and Drug Administration