Developing Oral LT3 Therapy for Heart Failure - HFrEF
United States28 participantsStarted 2020-02-11
Plain-language summary
Investigation of the safety, feasibility, and preliminary efficacy of thyroid hormone therapy with Liothyronine (LT3) in individuals with heart failure with reduced ejection fraction (HFrEF) and low triiodothyronine (T3) syndrome by conducting a randomized, double-blind, placebo-controlled cross-over study with a two-week washout period between treatments.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Men and women aged ≥18 years
. NYHA Class I, II or III heart failure
. EF≤40 percent within the past year
. An implantable cardioverter-defibrillator (ICD)
. Stable doses of neurohormonal blockade for 30 days
. TSH and free T4 level within the laboratory reference range and total T3 level \<94 ng/dL
Exclusion criteria
. Hypertrophic or restrictive cardiomyopathy
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial combined two conditions — HFrEF and low T3 syndrome — so should I get my T3 thyroid levels tested to see if that's even relevant to my situation before we discuss whether findings from this trial apply to me?
2Since this was a Phase 1/Phase 2 trial, what do we actually know so far about whether oral T3 therapy is safe for someone with heart failure, and are there any heart rhythm concerns I should understand given that the study specifically monitored cardiac rhythm over 14 days?
3The trial is now completed — have any results been published or presented, and if so, what did they show about T3 levels and heart function in people with reduced ejection fraction like mine?
4Given that this trial was testing an oral form of T3 hormone for heart failure, how does that approach compare to the standard treatments you'd normally recommend for my stage of HFrEF, and is thyroid hormone therapy something worth pursuing on my path?
5Are there any follow-on trials or expanded access programs building on this study that might be worth looking into, or is it too early to know whether this treatment direction is heading toward wider clinical use?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cardiac Rhythm Monitoring by 14 Day Patch Rhythm Assessment
Timeframe: continuous during intervention (14 days)
. Severe lung disease, including treatment with oral steroids within past 6 months for exacerbation of obstructive lung disease or use of daytime supplemental oxygen