Levothyroxine around coronary bypass for people with subclinical hypothyroidism
Thyroid Hormone Replacement After Coronary Artery Bypass Grafting for Patients With Subclinical Hypothyroidism
This will test whether taking levothyroxine starting before surgery reduces heart complications and improves outlook after coronary artery bypass grafting in adults with subclinical hypothyroidism.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 338 (estimated) |
| Ages | 19 Years to 90 Years |
| Sex | All |
| Sponsor | Seoul National University Bundang Hospital Academic / other |
| Locations | 1 site (Seongnam-si) |
| Trial ID | NCT07380854 on ClinicalTrials.gov |
What this trial studies
Adults with subclinical hypothyroidism who are scheduled for elective coronary artery bypass grafting are randomly assigned to receive levothyroxine or no thyroid hormone replacement. Participants assigned to levothyroxine start the drug one day before surgery and have thyroid function checked regularly. Investigators track major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, and new arrhythmias) and other outcomes during follow-up visits for up to five years. Key eligibility includes age 19–90, normal free T4 and TSH >4 μIU/mL within 31 days before surgery, with exclusions for recent thyroid drug use, repeat or emergency CABG, or severe comorbidity with life expectancy under one year.
Who should consider this trial
Good fit: Ideal candidates are adults aged 19–90 with subclinical hypothyroidism (normal free T4 and TSH >4 μIU/mL) who are scheduled for first-time elective CABG and are not recently treated with thyroid drugs and have reasonable life expectancy.
Not a fit: Patients with normal thyroid function, treated overt hypothyroidism, emergency or repeat CABG, recent levothyroxine or antithyroid drug use, or severe comorbidities with life expectancy under one year are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, levothyroxine could lower rates of major cardiovascular complications and improve recovery and long-term prognosis after CABG for patients with subclinical hypothyroidism.
How similar studies have performed: Previous trials of levothyroxine for subclinical hypothyroidism have shown mixed and limited cardiovascular outcome data, so applying it in the perioperative CABG setting is relatively novel.
Eligibility criteria
Show full inclusion / 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)
Where this trial is running
Seongnam-si
- Department of Internal Medicine, Seoul National University Bundang Hospital — Seongnam-si, South Korea (Recruiting)
Study contacts
- Study coordinator: Min Joo Kim, Professor
- Email: chorong24@gmail.com
- Phone: +82-31-787-7855
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.