NCT04111536

Developing Oral LT3 Therapy for Heart Failure - HFpEF

Developing Oral LT3 Therapy For Heart Failure With Preserved Ejection Fraction

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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). The study will consist of two treatment periods - 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.

Conditions

• Heart Failure With Preserved Ejection Fraction
• Low Triiodothyronine Syndrome

Interventions

Type	Name	Description
DRUG	liothyronine	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.
OTHER	Placebo	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.

Timeline

• Start date: 2020-03-08
• Primary completion: 2023-10-31
• Completion: 2023-10-31
• First posted: 2019-10-01
• Last updated: 2025-01-08
• Results posted: 2025-01-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study