Heart Transplant Failure, Heart Transplant Infection
Conditions
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.
Interventions
DRUGLevothyroxine
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.
DRUGNormal saline
Placebo will be normal saline and will be dosed at the same rate and time as the study drug.
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants who receive Levothyroxine's vasopressor use compared to number of participants who receive normal saline's vasopressor use. | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | Measured as a yes or no diagnosis. |
| 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 | 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) |
| Do the participants have improved cardiac output? | 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) |
Countries
United States
Contacts
CONTACTCorinne Dietz
CONTACTLea Daran
PRINCIPAL_INVESTIGATORJason Smith, MD
University of California, San Francisco
Outcome results
None listed