Trials / Completed
CompletedNCT04112316
Developing Oral LT3 Therapy for Heart Failure - HFrEF
Developing Oral LT3 Therapy For Heart Failure With Reduced 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 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.
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 reduced ejection fraction (HFrEF). 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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Liothyronine | 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. |
| OTHER | Placebo | 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. |
Timeline
- Start date
- 2020-02-11
- Primary completion
- 2023-10-31
- Completion
- 2023-10-31
- First posted
- 2019-10-02
- Last updated
- 2024-12-24
- Results posted
- 2024-12-24
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04112316. Inclusion in this directory is not an endorsement.