Levothyroxine for heart transplant recipients
Levothyroxine Supplementation for Heart Transplant Recipients: A Randomized Control Trial
This study is testing if taking levothyroxine can help heart transplant recipients live longer compared to those who receive a placebo.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 97 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT06428097 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the survival benefits of levothyroxine supplementation in heart transplant recipients compared to a placebo. Conducted at the University of California, San Francisco, it is a double-blinded, placebo-controlled, randomized study. Participants will be assigned to receive either levothyroxine or normal saline, with the aim of determining if levothyroxine improves post-operative survival rates. The study is motivated by previous findings that suggest thyroid hormone may enhance organ transplant outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are listed for heart transplantation and can provide informed consent.
Not a fit: Patients with pre-existing thyroid conditions or those who are allergic to levothyroxine may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve survival rates for heart transplant recipients.
How similar studies have performed: Previous retrospective studies have shown promising results, but this is the first randomized trial to test this hypothesis.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
San Francisco, California
- University of California, San Francisco — San Francisco, California, United States (Recruiting)
Study contacts
- Principal investigator: Jason Smith, MD — University of California, San Francisco
- Study coordinator: Sarah Sullivan
- Email: Sarah.sullivan2@ucsf.edu
- Phone: 415-353-7083
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.