Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California
Dates
study started
completion around
Principal Investigator
by Jason Smith, MD
Headshot of Jason Smith
Jason Smith

Description

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.

Official Title

Levothyroxine Supplementation for Heart Transplant Recipients: A Randomized Control Trial

Details

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.

Keywords

Heart Transplant Failure, Heart Transplant Infection, Levothyroxine, Normal saline

Eligibility

You can join if…

Open to people ages 18 years and up

  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.

You CAN'T join if...

  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.

Location

  • UCSF accepting new patients
    San Francisco California 94143 United States

Lead Scientist at UCSF

  • Jason Smith, MD
    Dr. Jason W. Smith is a cardiac and transplant surgeon who specializes in heart transplantation and the use of mechanical circulatory support, such as artificial heart pumps and left ventricular assist devices.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT06428097
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 97 study participants
Last Updated