Actively Recruiting
Levothyroxine Supplementation for Heart Transplant Recipients: A Randomized Control Trial
Led by University of California, San Francisco · Updated on 2025-05-01
97
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
Levothyroxine Supplementation for Heart Transplant Recipients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be listed for heart transplantation
- Age 18 years or older
- Ability to understand and willingness to sign a written informed consent document
You will not qualify if you...
- Patients with pre-existing thyroid conditions including hypothyroidism, hyperthyroidism, or malignancy
- Patients with known allergy or intolerance to levothyroxine
- Patients who have participated in another investigational drug study within the past 30 days
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 18 to 38 hours starting intra-operatively
Participants receive levothyroxine or placebo starting intra-operatively after the heart transplant surgery and continuing for the first 18 to 38 hours post-operation.
1 hospital stay including intra-operative and immediate post-operative care
Duration - Up to 12 months
Participants are monitored for outcomes including survival, graft function, and cardiac performance for up to 12 months after treatment.
Regular follow-up visits during 12 months post-treatment
Trial Site Locations
Total: 1 location
1
University of California, San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
Research Team
S
Sarah Sullivan
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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