Levothyroxine Supplementation for Heart Transplant Recipients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-29

Study Completion Date

2027-03-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Heart Transplant Failure Heart Transplant Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Levothyroxine

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

Group Type EXPERIMENTAL

Levothyroxine

Intervention Type DRUG

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.

No Levothyroxine

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

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

Normal saline

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No