CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 28 enrolled
Drug / intervention
liothyronine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04111536
NCT04111536Phase 2Completed

Developing Oral LT3 Therapy For Heart Failure With Preserved Ejection Fraction

University of Pennsylvania·interventional·Posted Oct 1, 2019·Updated Jan 8, 2025

In Brief

A Phase 2 clinical trial evaluating liothyronine and Placebo for Heart Failure With Preserved Ejection Fraction and Low Triiodothyronine Syndrome. Completed, enrolled 28 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedOct 1, 2019
Enrollment StartMar 8, 2020
Primary CompletionOct 31, 2023
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 6.8 years ago

Interventions

liothyroninedrug

Each treatment period of liothyronine was approximately 8 weeks in duration, with weekly titration of study drug for four weeks, followed by a maintenance dose for 4 weeks, then 2-week washout before crossing over to receive the alternate therapy - placebo.

Placeboother

Each treatment period of placebo was approximately 8 weeks in duration, with weekly titration of study drug for four weeks, followed by a maintenance dose for 4 weeks, then 2-week washout before crossing over to receive the alternate therapy - LT3.