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

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Northwell Health

Status and phase

Completed
Phase 1

Conditions

Atrial Fibrillation

Treatments

Drug: Triiodothyronine
Drug: triiodothyronine

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

280 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Quadruple Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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