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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-90
SponsorSeoul National University Bundang Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • levothyroxine

    Drug

    Intervention description: Participants assigned to the LT4 group will begin receiving levothyroxine the day before CABG. The initial dose is 25 μg once daily, or 12.5 μg for participants weighing less than 60 kg. The dose will then be adjusted based on thyroid function test results to achieve target TSH levels of 0.4-2.0 μIU/mL.

Treatment groups

338 Participants
are divided into 2 treatment groups
Group A: LT4 groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

A composite of MACE within 4months after surgery

A composite of major adverse cardiovascular events (MACE), including cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, and the occurrence of new arrhythmias assessed within 4 months after CABG.

Time frame
within 4months after surgery

Secondary outcomes

1

Number of participants who experience cardiovascular death within 4 months after surgery

Number of participants who experience cardiovascular death within 4 months after CABG

Time frame
within 4months after surgery
2

Number of participants who experience nonfatal myocardial infarction within 4 months after surgery

Number of participants who experience nonfatal myocardial infarction within 4 months after CABG

Time frame
within 4months after surgery
3

Number of participants who experience nonfatal stroke within 4 months after surgery

Number of participants who experience nonfatal stroke within 4 months after CABG

Time frame
within 4months after surgery
4

Number of participants who experience new arrhythmia within 4 months after surgery

Number of participants who experience new arrhythmia within 4 months after CABG

Time frame
within 4months after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.