## Protocol Section
### Identification Module
**NCT ID:** NCT06428097

**Acronym:** Levo

**Brief Title:** Levothyroxine Supplementation for Heart Transplant Recipients

**Official Title:** Levothyroxine Supplementation for Heart Transplant Recipients: A Randomized Control Trial

#### Organization Study ID Info
**ID:** 23-39323
#### Organization
**Class:** OTHER
**Full Name:** University of California, San Francisco
### Status Module
#### Completion Date
**Date:** 2027-03-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-29

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2027-03-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-03-29

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-03
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of California, San Francisco

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Is US Export:** True

**Oversight Has DMC:** True

### Description Module

**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.

### Conditions Module

**Conditions:**

- Heart Transplant Failure

- Heart Transplant Infection

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 97

**Type:** ESTIMATED

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Drug: Levothyroxine

**Label:** Levothyroxine

**Type:** EXPERIMENTAL

#### Arm Group 2

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

**Intervention Names:**

- Drug: Normal saline

**Label:** No Levothyroxine

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Levothyroxine

**Description:** 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.

**Name:** Levothyroxine

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- No Levothyroxine

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

**Name:** Normal saline

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** 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)

**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

#### Secondary Outcomes

**Description:** Measured as a yes or no diagnosis.

**Measure:** 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

**Description:** 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)

**Measure:** 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

**Description:** Cardiac output is calculated using stroke volume and heart rate and measured in liters/minute.

(Cardiac output = stroke volume x heart rate)

**Measure:** 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

### Eligibility Module

**Eligibility Criteria:** 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.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** Lea.daran@ucsf.edu

**Name:** Lea Daran

**Phone:** 415-502-4320

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** San Francisco

**Contacts:**

***Contact 1:***

- **Email:** Lea.daran@ucsf.edu

- **Name:** Lea Daran

- **Phone:** 415-502-4320

- **Role:** CONTACT

***Contact 2:***

- **Name:** Jason Smith, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** University of California, San Francisco

**State:** California

**Status:** RECRUITING

**Zip:** 94143

#### Overall Officials

**Official 1:**

**Affiliation:** University of California, San Francisco

**Name:** Jason Smith, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** YES

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
