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CompletedNCT00289367Updated May 20, 2008

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

A Phase 1 interventional study of Triiodothyronine and triiodothyronine in Atrial Fibrillation, sponsored by Northwell Health. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2008-05-20.

Sponsored by Northwell Health · Phase 1, Interventional, and Prevention

Phase
Phase 1
Study type
Interventional
Enrollment
280
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Atrial Fibrillation

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03

In context

Atrial Fibrillation

3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.

This study's planned enrollment of 280 is above the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Northwell Health is the lead sponsor of 463 studies on the registry; 109 are open to participants now.

Of its 40 completed or terminated interventional studies of FDA-regulated products, 20 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
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

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.
05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Single group
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
280 participants (estimated)

Interventions

  • DrugTriiodothyronine

    0.8 mcg/kg bolus loading dose followed by a six hour infusion of 0.8 mcg/kg/6hr.

  • Drugtriiodothyronine

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

06

What researchers measure

Primary outcomes

  1. incidence of atrial fibrillation

    Time frame: during hospitalization

07

Study locations

1 site
  • North Shore University Hospital
    Manhasset, New York 11030, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 20, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00289367
Lead sponsor
Northwell Health
Collaborators
Thomas and Jeanne Elmezzi Foundation
First posted
Feb 9, 2006
Start date
Feb 2006
Primary completion
Aug 2006
Completion
May 2008
Last update
May 20, 2008

Study contacts

Irwin Klein, MD
principal investigator · North Shore University Hospital
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2008. You cannot join it, but the record below documents what was studied.

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