Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06428097
Status:
RECRUITING
Last Update Posted:
2024-05-31
First Post:
2024-05-03
Brief Title:
Levothyroxine Supplementation for Heart Transplant Recipients
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Levothyroxine Supplementation for Heart Transplant Recipients A Randomized Control Trial
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Levo
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None