Recruiting
Phase 1

Levothyroxine

Sponsor:

UCLA

Code:

NCT06428097

Conditions

Heart Transplant Failure

Heart Transplant Infection

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Levothyroxine

Normal saline

Study Details

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.

Conditions

Heart Transplant Failure

Heart Transplant Infection

Study ID

NCT06428097

Start date

Mar 29, 2024

Status verified date

Aug, 2026

Completion date

Mar 1, 2027

Anticipated

Primary completion date

Mar 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

97 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Levothyroxine

Patients will be double-blinded and randomized to receive levothyroxine.

placebo comparator: No Levothyroxine

Patients will be double-blinded and randomized to receive no levothyroxine. The placebo will be normal saline.

Interventions

Levothyroxine

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.

Normal saline

Placebo will be normal saline and will be dosed at the same rate and time as the study drug.

Primary outcome measure

  • Number of participants who receive Levothyroxine's vasopressor use compared to number of participants who receive normal saline's vasopressor use. [ Time Frame: 35 months total completion, 18 months accrual, 12 months follow up and 5 months data analysis ]

Central Contacts and Locations

Central contacts

Corinne Dietz

415-353-7083Corinne.dietz@ucsf.edu

Lea Daran

415-502-4320Lea.daran@ucsf.edu

Locations

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Sarah Sullivan

415-353-7083Sarah.sullivan2@ucsf.edu

Principal Investigator:

Jason Smith, MD

More Information

Sponsor

University of California, San Francisco

Last update posted

Aug 13, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2026-08-13.