Levothyroxine Supplementation for Heart Transplant Recipients (Levo)

Levothyroxine Supplementation for Heart Transplant Recipients: A Randomized Control Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Transplant Infection; Heart Transplant Failure
• Intervention / Treatment: Drug: Levothyroxine; Drug: Normal saline

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.

• Study Type: Interventional
• Enrollment (Estimated): 97
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Sarah Sullivan; Phone Number: 415-353-7083; Email: Sarah.sullivan2@ucsf.edu

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • Recruiting
      • University of California, San Francisco
      • Principal Investigator: Jason Smith, MD
      • Contact: Sarah Sullivan; Phone Number: 415-353-7083; Email: Sarah.sullivan2@ucsf.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Levothyroxine; Patients will be double-blinded and randomized to receive levothyroxine.	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.
Placebo Comparator: No Levothyroxine; Patients will be double-blinded and randomized to receive no levothyroxine. The placebo will be normal saline.	Drug: Normal saline; Placebo will be normal saline and will be dosed at the same rate and time as the study drug.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants who receive Levothyroxine's vasopressor use compared to number of participants who receive normal saline's vasopressor use.	Measured using the vasoactive-inotropic score (VIS) scale. VIS calculation: dopamine dose (μg/kg/min) + dobutamine dose (μg/kg/min) + 100 × epinephrine dose (μg/kg/min) + 10 × milrinone dose (μg/kg/min) + 10 000 × vasopressin dose (unit/kg/min) + 100 × norepinephrine dose (μg/kg/min)	35 months total completion, 18 months accrual, 12 months follow up and 5 months data analysis

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Do the participants receiving levothyroxine experience lower frequencies of primary graft dysfunction?	Measured as a yes or no diagnosis.	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?	Measured using the vasoactive-inotropic score (VIS) scale. VIS calculation: dopamine dose (μg/kg/min) + dobutamine dose (μg/kg/min) + 100 × epinephrine dose (μg/kg/min) + 10 × milrinone dose (μg/kg/min) + 10 000 × vasopressin dose (unit/kg/min) + 100 × norepinephrine dose (μg/kg/min)	35 months total completion, 18 months accrual, 12 months follow up and 5 months data analysis
Do the participants have improved cardiac output?	Cardiac output is calculated using stroke volume and heart rate and measured in liters/minute. (Cardiac output = stroke volume x heart rate)	35 months total completion, 18 months accrual, 12 months follow up and 5 months data analysis

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: Jason Smith, MD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: May 3, 2024
• First Submitted That Met QC Criteria: May 22, 2024
• First Posted (Actual): May 24, 2024

Study Record Updates

• Last Update Posted (Actual): May 1, 2025
• Last Update Submitted That Met QC Criteria: April 28, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 23-39323

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes