Thyroid Hormone Replacement After Coronary Artery Bypass Grafting for Patients With Subclinical Hypothyroidism (RepleniSH)

Seoul National University

Status

Enrolling

Conditions

Subclinical Hypothyroidism

Treatments

Drug: levothyroxine

Study type

Interventional

Funder types

Other

Identifiers

NCT07380854

IRB-B-2110-717-003

Details and patient eligibility

About

The goal of this clinical trial is to find out whether levothyroxine reduces complications and improves the prognosis of patients with subclinical hypothyroidism (SCH) undergoing coronary artery bypass grafting (CABG).

The main questions this study aims to answer are:

• Does levothyroxine reduce major adverse cardiovascular events (MACE), including cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, and new arrhythmias, in SCH patients undergoing CABG? Researchers will compare patients who take levothyroxine with those who do not.

Participants will:

Be randomly assigned to either receive levothyroxine or not
Start the medication one day before surgery if assigned to the treatment group.
Have regular follow-up visits to check thyroid function and cardiovascular events for up to five years after surgery.

Enrollment

338 estimated patients

Sex

All

Ages

19 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Eligibility Criteria

Adults aged 19 to 90 years.
Patients scheduled to undergo coronary artery bypass graft (CABG) surgery.
Subclinical hypothyroidism (SCH), defined as a normal free thyroxine (free T4) level and a thyroid-stimulating hormone (TSH) level greater than 4 μIU/mL, based on testing performed within 31 days prior to surgery.

Exclusion Criteria:

Patients who underwent repeat or emergency CABG surgery
Use of LT4 within the previous 4 weeks
Use of antithyroid drug use (propylthiouracil, methimazole, or carbimazole) within the previous 3 months
Severe comorbid conditions with a life expectancy of less than 1 year (e.g. advanced malignancy)