NCT00289367

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
280

participants targeted

Target at P75+ for phase_1 atrial-fibrillation

Timeline
Completed

Started Feb 2006

Typical duration for phase_1 atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

February 7, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 9, 2006

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

May 20, 2008

Status Verified

May 1, 2008

Enrollment Period

6 months

First QC Date

February 7, 2006

Last Update Submit

May 19, 2008

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • incidence of atrial fibrillation

    during hospitalization

Interventions

triiodothyronineDRUG

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

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

North Shore University Hospital

Manhasset, New York, 11030, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Triiodothyronine

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ThyroninesThyroid HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsThyroxineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Irwin Klein, MD

    North Shore University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 7, 2006

First Posted

February 9, 2006

Study Start

February 1, 2006

Primary Completion

August 1, 2006

Study Completion

May 1, 2008

Last Updated

May 20, 2008

Record last verified: 2008-05

Locations

US(1)