Developing Oral LT3 Therapy for Heart Failure - HFpEF (DOT3HF-HFpEF)

[helvella]

Just looking for something else, and noticed this ongoing study.

Developing Oral LT3 Therapy for Heart Failure - HFpEF (DOT3HF-HFpEF)

Study Overview

Brief Summary:

Investigation of the safety, feasibility, and preliminary efficacy of thyroid hormone therapy with Liothyronine (LT3) in individuals with heart failure with preserved ejection fraction (HFpEF) and low triiodothyronine (T3) syndrome by conducting a randomized, double-blind, placebo-controlled cross-over study with a two-week washout period between treatments.

Detailed Description:

The overall goal is to determine the safety, feasibility, and preliminary efficacy of administering oral LT3 therapy in the study population of participants with Heart Failure with preserved ejection fraction (HFpEF). Each treatment period will be approximately 8 weeks in duration, with weekly titration of study drug for 4 weeks, followed by a maintenance dose for 4 weeks, then 2-week washout before crossing over to the other arm (placebo or drug). LT3 will be titrated to T3 levels.

beta.clinicaltrials.gov/stu...

Thought it might be interesting in the first place for those warned off liothyronine due to its impact on the heart! The study is not complete and reported, hence only of passing interest.

[humanbean]

I think this would give many UK endocrinologists a fit.

[helvella in reply to humanbean]

Or a heart attack?

[humanbean in reply to helvella]

Ooh, that would been a better ending to my comment! 😁

[tattybogle]

"LT3 will be titrated to T3 levels"

What .... ignore the TSH ?

..... they can't do that .. the sky will fall in, the patients heads will explode , and/ or they'll get so hooked on feeling 'energetic' that they'll need to be escorted to London and booked into Jim's T3 rehab clinic.

[helvella in reply to tattybogle]

I wasn't clear whether that was FT3 or TT3 - which is why I ignored it!

[humanbean]

Each treatment period will be approximately 8 weeks in duration, with weekly titration of study drug for 4 weeks, followed by a maintenance dose for 4 weeks, then 2-week washout before crossing over to the other arm (placebo or drug).

I've seen a few references to "washing out" thyroid hormones in research involving thyroid disease. It always gives me a horrible feeling as I imagine myself being in the shoes of those going through it. It would be a nightmare!

Based on the exclusion criteria none of the participants will have treated hypothyroidism or hyperthyroidism, although we all know that diagnosis of various thyroid conditions can be delayed for years, so some people with untreated thyroid disease might creep in whether the researchers want this or not.

I wonder what they mean by a "maintenance dose" of T3 "for four weeks" since theoretically their exclusion criteria says they won't be using people with thyroid disease. So what would a maintenance dose consist of?

[helvella in reply to humanbean]

Maybe email the listed contact?

[tattybogle in reply to humanbean]

entry criteria was 'low T3 syndrome' so... assuming that means 'T3 below range' ? .... presumably maintenance dose is 'one that keeps T3 in range' .. don't know if that's TT3 or fT3 .