Levothyroxine Supplementation for Heart Transplant Recipients

University of California San Francisco (UCSF)

Status and phase: Enrolling; Phase 1

Conditions: Heart Transplant Infection; Heart Transplant Failure

Treatments: Drug: Normal saline; Drug: Levothyroxine

Study type: Interventional

Funder types: Other

Identifiers

NCT06428097

23-39323

Details and patient eligibility

About

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.

Full description

Studies have shown that thyroid hormone results in a higher number of organs available for transplant. Increasingly, thyroid hormone supplementation is used amongst transplant donors. However, it is not the current standard of practice to supplement recipients without a prior medical history of hypothyroidism with levothyroxine. Two large retrospective studies have demonstrated improved 30-days survival and lower risk of all-cause mortality for heart transplant recipients who receive levothyroxine in the post-operative context. No randomized trials have tested this hypothesis and so the investigators aim to trial the use of levothyroxine for heart transplant recipients at University of California San Francisco using a double-blinded and placebo controlled randomized control trial study design. 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.

Enrollment: 97 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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97 participants in 2 patient groups, including a placebo group

Levothyroxine

Experimental group

Description:

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

Treatment:

Drug: Levothyroxine

No Levothyroxine

Placebo Comparator group

Description:

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

Treatment:

Drug: Normal saline