University of California, San Francisco
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.
Studies have shown that thyroid hormone results in a higher number of organs available for transplant. Increasingly, thyroid hormone supplementation is used amongst transplant donors. However, it is not the current standard of practice to supplement recipients without a prior medical history of hypothyroidism with levothyroxine. Two large retrospective studies have demonstrated improved 30-days survival and lower risk of all-cause mortality for heart transplant recipients who receive levothyroxine in the post-operative context. No randomized trials have tested this hypothesis and so the invest…
Inclusion Criteria: 1. Participants must be listed for heart transplantation 2. Age ≥18 years 3. Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: 1. Patients with pre-existing thyroid related condition including hypothyroidism, hyperthyroidism and malignancy 2. Patients with a known allergy or intolerance to levothyroxine 3. Patients participating in another study evaluating an investigational drug within the past 30 days.
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.
Placebo will be normal saline and will be dosed at the same rate and time as the study drug.
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