NCT07380854 Thyroid Hormone Replacement After Coronary Artery Bypass Grafting for Patients With Subclinical Hypothyroidism
| NCT ID | NCT07380854 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Seoul National University Bundang Hospital |
| Condition | Subclinical Hypothyroidism |
| Study Type | INTERVENTIONAL |
| Enrollment | 338 participants |
| Start Date | 2022-02-27 |
| Primary Completion | 2032-02-26 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 338 participants in total. It began in 2022-02-27 with a primary completion date of 2032-02-26.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07380854 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, up to 90 Years, studying Subclinical Hypothyroidism. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07380854 currently recruiting?
Yes, NCT07380854 is actively recruiting participants. Contact the research team at chorong24@gmail.com for enrollment information.
Where is the NCT07380854 trial being conducted?
This trial is being conducted at Seongnam-si, South Korea.
Who is sponsoring the NCT07380854 clinical trial?
NCT07380854 is sponsored by Seoul National University Bundang Hospital. The trial plans to enroll 338 participants.