NCT06428097 Levothyroxine Supplementation for Heart Transplant Recipients
| NCT ID | NCT06428097 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | University of California, San Francisco |
| Condition | Heart Transplant Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 97 participants |
| Start Date | 2024-03-29 |
| Primary Completion | 2027-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 97 participants in total. It began in 2024-03-29 with a primary completion date of 2027-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Jason Smith, MD
PRINCIPAL INVESTIGATOR
University of California, San Francisco
Frequently Asked Questions
Who can join the NCT06428097 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heart Transplant Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06428097 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06428097 currently recruiting?
Yes, NCT06428097 is actively recruiting participants. Contact the research team at Sarah.sullivan2@ucsf.edu for enrollment information.
Where is the NCT06428097 trial being conducted?
This trial is being conducted at San Francisco, United States.
Who is sponsoring the NCT06428097 clinical trial?
NCT06428097 is sponsored by University of California, San Francisco. The principal investigator is Jason Smith, MD at University of California, San Francisco. The trial plans to enroll 97 participants.