University of California, San Francisco
San Francisco, California, 94143, United States
Location status: Recruiting
NCT Number: NCT06428097
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 1
San Francisco, California, 94143, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Placebo will be normal saline and will be dosed at the same rate and time as the study drug.
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)
Time frame: 35 months total completion, 18 months accrual, 12 months follow up and 5 months data analysis
Measured as a yes or no diagnosis.
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)
Time frame: 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)
Contact information is provided by the study sponsor or research team.
University of California, San Francisco
Other
Levothyroxine Supplementation for Heart Transplant Recipients: A Randomized Control Trial
Acronym: Levo
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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