Heart Transplant FailurePhase 1LevoNCT06428097
Levothyroxine Supplementation for Heart Transplant Recipients
A Phase 1 study testing Levothyroxine and Normal saline in people with Heart Transplant Failure and Heart Transplant Infection, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Transplant Failure, Heart Transplant Infection
- What is being tested?
- Levothyroxine and Normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 97 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Mar 2024to 1 Mar 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must be listed for heart transplantation
- Age ≥18 years
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California, San Francisco
San Francisco, California, 94143
Sarah Sullivan, 415-353-7083, Sarah.sullivan2@ucsf.edu
Jason Smith, MD
About this study
Official title: 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.
Read the 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.
- Being tested
- Levothyroxine, Normal saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevothyroxineDrug
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 salineDrug
Placebo will be normal saline and will be dosed at the same rate and time as the study drug.
| Study group | Role | What they receive |
|---|---|---|
| Levothyroxine | Experimental | Patients will be double-blinded and randomized to receive levothyroxine. Receives: Drug: Levothyroxine |
| No Levothyroxine | Placebo comparator | Patients will be double-blinded and randomized to receive no levothyroxine. The placebo will be normal saline. Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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?
Measured as a yes or no diagnosis.
Measured: 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)
Measured: 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)
Measured: 35 months total completion, 18 months accrual, 12 months follow up and 5 months data analysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2024
- Study start29 Mar 2024
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Transplant FailureStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 97 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jason Smith, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06428097
- Sponsor's protocol ID
- 23-39323
- Acronym
- Levo
- Status last verified
- Aug 2026
- First submitted
- 3 May 2024
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Levothyroxine Supplementation for Heart Transplant Recipients: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06428097
- Acronym / sponsor ID
- Levo / 23-39323
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 97 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 29 Mar 2024 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 24 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levothyroxine | Experimental | Drug: LevothyroxinePatients will be double-blinded and randomized to receive levothyroxine. |
| No Levothyroxine | Placebo comparator | Drug: Normal salinePatients will be double-blinded and randomized to receive no levothyroxine. The placebo will be normal saline. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants must be listed for heart transplantation
- Age ≥18 years
- Ability to understand and the willingness to sign a written informed consent document.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LevothyroxineDosing 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 | Levothyroxine |
| Normal salinePlacebo will be normal saline and will be dosed at the same rate and time as the study drug. | Drug | No Levothyroxine |
Primary outcome
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)
3 secondary outcomes
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jason Smith, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Levothyroxine and Normal saline in people with Heart Transplant Failure and Heart Transplant Infection, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Corinne Dietz (415-353-7083, Corinne.dietz@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.