Levothyroxine Supplementation for Heart Transplant Recipients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Levothyroxine, Normal saline.
- Who it may be relevant to
- Registry conditions: Heart Transplant Failure, Heart Transplant Infection. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Levothyroxine Supplementation for Heart Transplant Recipients: A Randomized Control Trial
Overview
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.
Interventions
- Drug 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. - Drug Normal saline
Placebo will be normal saline and will be dosed at the same rate and time as the study drug.
Primary outcome measures
- 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]
Secondary outcome measures (3)
- Do the participants receiving levothyroxine experience lower frequencies of primary graft dysfunction? [Time frame: 35 months total completion, 18 months accrual, 12 months follow up and 5 months data analysis]
- Does the total vasoactive-inotropic score (VIS) decrease for patients who receive levothyroxine? [Time frame: 35 months total completion, 18 months accrual, 12 months follow up and 5 months data analysis]
- Do the participants have improved cardiac output? [Time frame: 35 months total completion, 18 months accrual, 12 months follow up and 5 months data analysis]
Eligibility criteria
Inclusion criteria
- Participants must be listed for heart transplantation
- Age ≥18 years
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion criteria
- Patients with pre-existing thyroid related condition including hypothyroidism, hyperthyroidism and malignancy
- Patients with a known allergy or intolerance to levothyroxine
- Patients participating in another study evaluating an investigational drug within the past 30 days.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of California, San Francisco — San Francisco
Identifiers
NCT: NCT06428097 · 23-39323