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Study of T3 on the Incidence of Atrial Fibrillation in Patients Undergoing Cardiac Surgery

This study has been completed.
Thomas and Jeanne Elmezzi Foundation
Information provided by:
Northwell Health Identifier:
First received: February 7, 2006
Last updated: May 19, 2008
Last verified: May 2008
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.

Condition Intervention Phase
Atrial Fibrillation Drug: Triiodothyronine Drug: triiodothyronine Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomized Prospective Study of T3 on the Incidence of Post-Operative Atrial Fibrillation in Patients Undergoing Cardiac Surgery

Resource links provided by NLM:

Further study details as provided by Northwell Health:

Primary Outcome Measures:
  • incidence of atrial fibrillation [ Time Frame: during hospitalization ]

Estimated Enrollment: 280
Study Start Date: February 2006
Study Completion Date: May 2008
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    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.

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00289367

United States, New York
North Shore University Hospital
Manhasset, New York, United States, 11030
Sponsors and Collaborators
Northwell Health
Thomas and Jeanne Elmezzi Foundation
Principal Investigator: Irwin Klein, MD North Shore University Hospital
  More Information

Responsible Party: Irwin Klein, North Shore University Hospital Identifier: NCT00289367     History of Changes
Other Study ID Numbers: 05-075
Study First Received: February 7, 2006
Last Updated: May 19, 2008

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes processed this record on September 21, 2017