Levothyroxine Supplementation for Heart Transplant Recipients

Heart Transplant Failure Clinical Trial

— Levo  

Official title:

Levothyroxine Supplementation for Heart Transplant Recipients: A Randomized Control Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06428097
• Other study ID #: 23-39323
• Status: Recruiting
• Phase: Phase 1
• Start date: March 29, 2024
• Est. completion date: March 1, 2027

Study information

• Verified date: May 2024
• Source: University of California, San Francisco
• Contact: Lea Daran
• Phone: 415-502-4320
• Email: Lea.daran[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. It will be double-blinded and placebo-control; participants will be randomized to receive levothyroxine or receive no levothyroxine.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 97
• Est. completion date: March 1, 2027
• Est. primary completion date: March 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Transplant Failure
• Heart Transplant Infection

Intervention

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

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Do the participants receiving levothyroxine experience lower frequencies of primary graft dysfunction?	Measured as a yes or no diagnosis.	35 months total completion, 18 months accrual, 12 months follow up and 5 months data analysis
Secondary	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)	35 months total completion, 18 months accrual, 12 months follow up and 5 months data analysis
Secondary	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)	35 months total completion, 18 months accrual, 12 months follow up and 5 months data analysis