Heart Transplant Infection / Normal saline / Heart Transplant Failure · Phase 1 Trial

Levothyroxine Supplementation for Heart Transplant Recipients

ClinicalTrials.gov · August 13, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a planned Phase 1 randomized controlled trial of levothyroxine supplementation in heart transplant recipients, designed to compare vasopressor use between treatment and placebo groups. The study is currently recruiting and has not yet reported results; this registry record describes the protocol only.

What was studied

Phase 1, Interventional, Randomized, Parallel, Double masking, Treatment purpose. Heart Transplant Failure, Heart Transplant Infection; age from 18 Years. Intervention: Levothyroxine. Compared with: No Levothyroxine — Placebo Comparator. n = 97. 1 site: United States.

Key findings

Safety

Phase 1 design indicates feasibility and safety focus, not efficacy demonstration.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a Phase 1 interventional trial still recruiting; no results are reported in this registry record, making it a feasibility and safety study with no efficacy data yet available.

Study design

As stated by the source record.

MethodsPrimary outcome measure: Number of participants who receive Levothyroxine's vasopressor use compared to number of participants who receive normal saline's vasopressor use. (assessed at 35 months total completion, 18 months accrual, 12 months follow up and 5 months…)

DesignPhase 1, Interventional, Randomized, Parallel, Double masking, Treatment purpose

PopulationHeart Transplant Failure, Heart Transplant Infection; age from 18 Years

Sample size97

InterventionLevothyroxine

ComparatorNo Levothyroxine — Placebo Comparator

Setting1 site: United States

Reported figures

Quoted from the source exactly as published.

Planned sample size97

Study phasePhase 1

Primary outcome measureNumber of participants who receive levothyroxine's vasopressor use compared to number of participants who receive normal saline's vasopressor use

Total study duration35 months

Accrual period18 months

Follow-up period12 months

Caveats

This is a registry record only; no results are reported. The study is still recruiting.
Phase 1 design indicates feasibility and safety focus, not efficacy demonstration.
Single-centre study limits generalizability to other transplant programmes.
Primary outcome wording is ambiguous in the registry; exact vasopressor use definition and threshold are not clarified in this text.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Prospective, randomized, double-blind, placebo-controlled design at single centre.

Directness

strong

Hard endpoint: vasopressor use in post-heart-transplant patients; clinically relevant.

Consistency

insufficient

No results reported; consistency cannot be assessed from registry record alone.

Risk of bias

moderate

Planned blinding and randomization reduce bias; single-centre setting limits generalizability.

Sample adequacy

limited

Phase 1 trial with estimated 97 participants; small, exploratory sample.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT06428097). This is a study registration, not published results. Lead sponsor: University of California, San Francisco. Recruitment status: RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 97 participants (ESTIMATED). Conditions: Heart Transplant Failure, Heart Transplant Infection. Interventions: DRUG: Levothyroxine; DRUG: Normal saline. Primary outcome measures: Number of participants who receive Levothyroxine's vasopressor use compared to number of participants who receive normal saline's vasopressor use. , 35 months total completion, 18 months accrual, 12 months follow up and 5 months data analysis. 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Heart Transplant InfectionUniversity of California, San FrancisNormal salineHeart Transplant FailureNCT06428097Levothyroxine