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Hormone Therapy

Levothyroxine for Heart Transplant Recipients (Levo Trial)

Phase 1
Recruiting
Led By Jason Smith, MD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥18 years
Participants must be listed for heart transplantation
Must not have
Patients with pre-existing thyroid related condition including hypothyroidism, hyperthyroidism and malignancy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 35 months total completion, 18 months accrual, 12 months follow up and 5 months data analysis

Summary

"This trial will be conducted at a university medical center to study whether taking levothyroxine after a heart transplant improves survival compared to not taking it. The study will be double-blinded and participants

Who is the study for?
This trial is for adults over 18 who are listed for a heart transplant and can consent to participate. It's not open to those with thyroid conditions, allergies to levothyroxine, or anyone in another drug study within the last month.
What is being tested?
The study compares survival benefits of taking levothyroxine versus not taking it after a heart transplant. Participants at UCSF will be randomly assigned to either get levothyroxine or a placebo without knowing which one they receive.
What are the potential side effects?
Potential side effects of levothyroxine may include changes in appetite, weight fluctuations, temperature sensitivity, fatigue, sweating, and mood swings. The placebo (normal saline) typically has no side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
Select...
I am on the waiting list for a heart transplant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a thyroid condition, such as underactive or overactive thyroid or thyroid cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~35 months total completion, 18 months accrual, 12 months follow up and 5 months data analysis
This trial's timeline: 3 weeks for screening, Varies for treatment, and 35 months total completion, 18 months accrual, 12 months follow up and 5 months data analysis for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of participants who receive Levothyroxine's vasopressor use compared to number of participants who receive normal saline's vasopressor use.
Secondary study objectives
Do the participants have improved cardiac output?
Do the participants receiving levothyroxine experience lower frequencies of primary graft dysfunction?
Does the total vasoactive-inotropic score (VIS) decrease for patients who receive levothyroxine?

Side effects data

From 2022 Phase 4 trial • 52 Patients • NCT04288115
5%
Gangrene of toe
5%
catheter ablation of arrhythmogenic focus
5%
revision posterior decompression cervical cord and fusion
5%
transurethral prostatectomy
5%
diarrhea
5%
angina pectoris
5%
fall
5%
fluoroscopy guided percutaneous insertion of drug eluting stent into coronary artery with contrast
5%
hypertensive disorder
5%
low blood pressure
5%
bronchitis
5%
intravitreal injection of anti-vascular endothelial growth factor
5%
carcinoma of prostate
5%
paresthesia of upper limb
5%
restenosis
5%
scalp itchy
5%
shoulder pain
5%
simple extraction of tooth
5%
spasm
5%
polyp of transverse colon
5%
polyp of sigmoid colon
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo Group ("Real Discontinuation")
Levothyroxine Group ("Sham Discontinuation")

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: LevothyroxineExperimental Treatment1 Intervention
Patients will be double-blinded and randomized to receive levothyroxine.
Group II: No LevothyroxinePlacebo Group1 Intervention
Patients will be double-blinded and randomized to receive no levothyroxine. The placebo will be normal saline.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Levothyroxine
2013
Completed Phase 4
~3840

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,580 Previous Clinical Trials
15,177,403 Total Patients Enrolled
57 Trials studying Infections
34,173 Patients Enrolled for Infections
Jason Smith, MDPrincipal InvestigatorUniversity of California, San Francisco
2 Previous Clinical Trials
7 Total Patients Enrolled
~65 spots leftby Mar 2027
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