Randomized Trial of Levothyroxine vs Placebo to Improve Survival After Heart Transplant

What this Trial Is About

This research aims to evaluate the survival benefits of levothyroxine compared with no levothyroxine in patients who have undergone heart transplantation. The study is a prospective, randomized, double-blinded, placebo-controlled trial conducted at a single tertiary referral academic medical center. It responds to previous retrospective studies suggesting improved 30-day survival and lower mortality risk with levothyroxine use after heart transplant. Participants will be randomly assigned to one of two groups one to receive levothyroxine and the other to receive a placebo of normal saline. The levothyroxine dosing follows established protocols starting intra-operatively for 18 to 38 hours after the donor heart is implanted. This study includes an 18-month enrollment period, a 12-month follow-up, and a 5-month data analysis phase, totaling 35 months. During the study, researchers will monitor vasopressor use as the primary outcome measure, comparing levothyroxine and placebo groups. Secondary outcomes include frequency of primary graft dysfunction, vasoactive-inotropic score changes, and cardiac output improvements. Participants will undergo regular assessments and monitoring throughout the study timeline to evaluate these effects and overall safety.

Levothyroxine Supplementation for Heart Transplant Recipients