Levothyroxine Supplementation for Heart Transplant Recipients
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, San Francisco
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants must be listed for heart transplantation
Age ≥18 years
Ability to understand and the willingness to sign a written informed consent document.
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Levothyroxine
DrugDosing 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
DrugPlacebo will be normal saline and will be dosed at the same rate and time as the study drug.
Treatment groups
97 Participants
are divided into 2 treatment groupsGroup A: LevothyroxineExperimental treatment 1 intervention
Group B: No LevothyroxinePlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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)
Time frame
35 months total completion, 18 months accrual, 12 months follow up and 5 months data analysisSecondary outcomes
1
Do the participants receiving levothyroxine experience lower frequencies of primary graft dysfunction?
Measured as a yes or no diagnosis.
Time frame
35 months total completion, 18 months accrual, 12 months follow up and 5 months data analysis2
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)
Time frame
35 months total completion, 18 months accrual, 12 months follow up and 5 months data analysis3
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)
Time frame
35 months total completion, 18 months accrual, 12 months follow up and 5 months data analysisSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov