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Levothyroxine Supplementation for Heart Transplant Recipients

NCT06428097 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2025-05-01

No results posted yet for this study

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.

Conditions

  • Heart Transplant Failure
  • Heart Transplant Infection

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.

Sponsors & Collaborators

Principal Investigators

  • Jason Smith, MD · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-29
Primary Completion
2027-03-01
Completion
2027-03-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06428097 on ClinicalTrials.gov