Levothyroxine Supplementation for Heart Transplant Recipients

Phase 1

Recruiting

• Conditions: Heart Transplant Failure; Heart Transplant Infection
• Interventions: Drug: Normal saline; Drug: Levothyroxine

• Registration Number: NCT06428097
• Lead Sponsor: University of California, San Francisco

Brief 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.

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 Timeline

• Study Start: 2024-03-29
• Study First Submitted: 2024-05-03
• Study First Submitted QC: 2024-05-22
• Study First Posted: 2024-05-24
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-05-01
• Primary Completion: 2027-03-01
• Study Completion: 2027-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 97

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No Levothyroxine	Normal saline	Patients will be double-blinded and randomized to receive no levothyroxine. The placebo will be normal saline.
Levothyroxine	Levothyroxine	Patients will be double-blinded and randomized to receive levothyroxine.

Primary Outcome Measures

Name	Time	Method
Number of participants who receive Levothyroxine's vasopressor use compared to number of participants who receive normal saline's vasopressor use.	35 months total completion, 18 months accrual, 12 months follow up and 5 months data analysis	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)

Secondary Outcome Measures

Name	Time	Method
Does the total vasoactive-inotropic score (VIS) decrease for patients who receive levothyroxine?	35 months total completion, 18 months accrual, 12 months follow up and 5 months data analysis	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)
Do the participants have improved cardiac output?	35 months total completion, 18 months accrual, 12 months follow up and 5 months data analysis	Cardiac output is calculated using stroke volume and heart rate and measured in liters/minute.; (Cardiac output = stroke volume x heart rate)
Do the participants receiving levothyroxine experience lower frequencies of primary graft dysfunction?	35 months total completion, 18 months accrual, 12 months follow up and 5 months data analysis	Measured as a yes or no diagnosis.

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States