Clinical trial NCT06428097: Levothyroxine Supplementation for Heart Transplant Recipients
Official title: Levothyroxine Supplementation for Heart Transplant Recipients: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Heart Transplant Failure
Heart Transplant Infection
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2024-05-24
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

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.

Primary outcomes:
measure: Number of participants who receive Levothyroxine's vasopressor use compared to number of participants who receive normal saline's vasopressor use.
timeFrame: 35 months total completion, 18 months accrual, 12 months follow up and 5 months data analysis
Secondary outcomes:
measure: Do the participants receiving levothyroxine experience lower frequencies of primary graft dysfunction?
timeFrame: 35 months total completion, 18 months accrual, 12 months follow up and 5 months data analysis
measure: Does the total vasoactive-inotropic score (VIS) decrease for patients who receive levothyroxine?
timeFrame: 35 months total completion, 18 months accrual, 12 months follow up and 5 months data analysis
measure: Do the participants have improved cardiac output?
timeFrame: 35 months total completion, 18 months accrual, 12 months follow up and 5 months data analysis
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Jason Smith, MD
role: PRINCIPAL_INVESTIGATOR
References: