Levothyroxine Supplementation for Heart Transplant Recipients

NCT06428097 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 23-39323
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Transplant Failure; Heart Transplant Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• 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

• Do the participants have improved cardiac output?

  35 months total completion, 18 months accrual, 12 months follow up and 5 months data analysis

Study Arms (2)

Levothyroxine

EXPERIMENTAL

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

Drug: Levothyroxine

No Levothyroxine

PLACEBO COMPARATOR

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

Drug: Normal saline

Interventions

Levothyroxine 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.

Levothyroxine

Normal saline DRUG

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

No Levothyroxine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must be listed for heart transplantation
• Age ≥18 years
• Ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• Patients with pre-existing thyroid related condition including hypothyroidism, hyperthyroidism and malignancy
• Patients with a known allergy or intolerance to levothyroxine
• Patients participating in another study evaluating an investigational drug within the past 30 days.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

RECRUITING

MeSH Terms

Interventions

Thyroxine; Saline Solution

Intervention Hierarchy (Ancestors)

Thyroid Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Jason Smith, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Sullivan

CONTACT

415-353-7083; Sarah.sullivan2@ucsf.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2024
• First Posted: May 24, 2024
• Study Start: March 29, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: May 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)