RecruitingPhase 1NCT06428097

Levothyroxine Supplementation for Heart Transplant Recipients

Levothyroxine Supplementation for Heart Transplant Recipients: A Randomized Control Trial

Sponsor

University of California, San Francisco

Enrollment

97 participants

Start Date

Mar 29, 2024

Study Type

INTERVENTIONAL

Conditions

Heart Transplant Failure Heart Transplant Infection

Summary

This will be a prospective, randomized study performed at a single tertiary referral academic medical center (University of California San Francisco, CA), evaluating the survival benefits of levothyroxine compared with no levothyroxine for patients who have undergone heart transplant. It will be double-blinded and placebo-control; participants will be randomized to receive levothyroxine or receive no levothyroxine.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether giving thyroid hormone (levothyroxine) to heart transplant patients — both while they are waiting for a heart and after they receive one — can improve outcomes. Donor hearts often have disrupted thyroid hormone levels, which may affect how well the new heart functions. **You may be eligible if...** - You are 18 years old or older - You are currently on the waiting list for a heart transplant - You are able to understand and sign an informed consent form **You may NOT be eligible if...** - You already have a thyroid condition such as an underactive thyroid, overactive thyroid, or thyroid cancer - You have a known allergy or intolerance to levothyroxine (thyroid hormone medication) - You are currently participating in another clinical drug study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLevothyroxine

Dosing will be based on pre-existing protocols in the setting of organ donation.This will be the protocol for the first 18-38 hours starting intra-operatively after the donated heart is sewn in.

DRUGNormal saline

Placebo will be normal saline and will be dosed at the same rate and time as the study drug.