At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 28 enrolled

Drug / intervention

Liothyronine +1 moredrug

Likely dose

Liothyronine 5 mcgfrom 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/NCT04112316

NCT04112316Phase 2Completed

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Developing Oral LT3 Therapy For Heart Failure With Reduced Ejection Fraction

University of Pennsylvania·interventional·Posted Oct 2, 2019·Updated Dec 24, 2024

In Brief

A Phase 2 clinical trial evaluating Liothyronine and Placebo for Heart Failure With Reduced Ejection Fraction (HFrEF) and Low T3 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 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsHeart Failure With Reduced Ejection Fraction (HFrEF), Low T3 Syndrome

CountriesUnited States

CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI)

Timeline

Phase 2CompletedFinished

2020202120222023202420252026

First PostedOct 2019

Enrollment StartFeb 2020

Primary CompletionOct 2023

TodayJul 2026

First PostedOct 2, 2019

Enrollment StartFeb 11, 2020

Primary CompletionOct 31, 2023

TodayJul 2, 2026

Enrollment to primary: 3.7 yearsPosted 6.8 years ago

Interventions

Liothyroninedrug

Liothyronine (L-triiodothyronine or LT3) in the 5 mcg tablet dose formulation. Minimum LT3 dose was 2.5 mcg three times daily and the maximum LT3 dose was 12.5 mcg three times daily.

Placeboother

A placebo tablet matching in appearance to LT3 tablets. Minimum placebo tablet dose was 1/2 tablet three times daily and the maximum placebo dose was 2 1/2 tablets three times daily.