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NCT Number: NCT06428097

Levothyroxine Supplementation for Heart Transplant Recipients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of California, San Francisco

San Francisco, California, 94143, United States

Location status: Recruiting

Location contact

Jason Smith, MD

PRINCIPAL_INVESTIGATOR

Sarah Sullivan

CONTACT

[email protected]

415-353-7083

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

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.

normal saline

Drug

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

Primary outcomes

  1. Number of participants who receive Levothyroxine's vasopressor use compared to number of participants who receive normal saline's vasopressor use.

    Time frame: 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 outcomes

  1. Do the participants receiving levothyroxine experience lower frequencies of primary graft dysfunction?

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

    Measured as a yes or no diagnosis.

  2. Does the total vasoactive-inotropic score (VIS) decrease for patients who receive levothyroxine?

    Time frame: 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)

  3. Do the participants have improved cardiac output?

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Sarah Sullivan

CONTACT

[email protected]

415-353-7083

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

Levothyroxine Supplementation for Heart Transplant Recipients: A Randomized Control Trial

Acronym: Levo

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
May 24, 2024
Registry last updated
May 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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