Levothyroxine Supplementation for Heart Transplant Recipients

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT06428097
Phase
PHASE1
Status
Recruiting
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Conditions

  • Heart Transplant Failure
  • Heart Transplant Infection

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • Normal saline — DRUG
    Placebo will be normal saline and will be dosed at the same rate and time as the study drug.

Study Details

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.

Key Dates

Start date
Mar 29, 2024
Status verified
Apr 2025
Primary completion
Mar 1, 2027
Completion
Mar 1, 2027

Study Design

Enrollment
97 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Levothyroxine
    Patients will be double-blinded and randomized to receive levothyroxine.
  • Placebo Comparator: No Levothyroxine
    Patients will be double-blinded and randomized to receive no levothyroxine. The placebo will be normal saline.

Primary Outcome Measure

Number of participants who receive Levothyroxine's vasopressor use compared to number of participants who receive normal saline's vasopressor use. [ Time Frame: 35 months total completion, 18 months accrual, 12 months follow up and 5 months data analysis ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94143
Sarah Sullivan
[email protected]
415-353-7083
Jason Smith, MD (PRINCIPAL_INVESTIGATOR)

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By research site
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