Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levothyroxine | Experimental | Patients will be double-blinded and randomized to receive levothyroxine. |
|
| No Levothyroxine | Placebo Comparator | Patients will be double-blinded and randomized to receive no levothyroxine. The placebo will be normal saline. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levothyroxine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Does the total vasoactive-inotropic score (VIS) decrease for patients who receive levothyroxine? |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sarah Sullivan | Contact | 415-353-7083 | Sarah.sullivan2@ucsf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jason Smith, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | Recruiting | San Francisco | California | 94143 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013974 | Thyroxine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D013963 | Thyroid Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D024322 | Amino Acids, Aromatic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Normal saline | Drug | Placebo will be normal saline and will be dosed at the same rate and time as the study drug. |
|
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 |
| 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 |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |