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NCT04112316 · ClinicalTrials.gov registry record · Phase 1
Developing Oral LT3 Therapy for Heart Failure - HFrEF
A Phase 1 study of Heart Failure With Reduced Ejection Fraction (HFrEF) and Low T3 Syndrome, sponsored by University of Pennsylvania.
- Completed
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
- 1
- Study location
NCT04112316: Completed Phase 1 study of Heart Failure With Reduced Ejection Fraction (HFrEF) and Low T3 Syndrome, sponsored by University of Pennsylvania.
NCT04112316 is a Phase 1 study of Heart Failure With Reduced Ejection Fraction (HFrEF) and Low T3 Syndrome that has completed, run by University of Pennsylvania. The registered enrollment target is 28 participants, below the 538-participant average among 5 other Heart Failure With Reduced Ejection Fraction (HFrEF) trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04112316, a Phase 1 study of Heart Failure With Reduced Ejection Fraction (HFrEF) and Low T3 Syndrome, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Number of participants with atrial fibrillation or ventricular tachycardia \>= 4 beats
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Liothyronine
Study Locations (1)
Pennsylvania
- PennMedicine - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2020-02-11 |
| Est. Completion | 2023-10-31 |
| Phase | Phase 1 |
What the finished NCT04112316 record still lists
NCT04112316 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 538-participant average among 5 other Heart Failure With Reduced Ejection Fraction (HFrEF) trials with a reported enrollment target (95% lower).
The record links to 2 conditions, with Heart Failure With Reduced Ejection Fraction (HFrEF) appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04112316 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT04112316 about?
NCT04112316 is a clinical study titled "Developing Oral LT3 Therapy for Heart Failure - HFrEF". 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-ove...
What is the current status of trial NCT04112316?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2020-02-11. Estimated completion is 2023-10-31.
What conditions does trial NCT04112316 study?
This clinical trial studies the following conditions: Heart Failure With Reduced Ejection Fraction (HFrEF), Low T3 Syndrome.
What interventions are being tested in trial NCT04112316?
The interventions under investigation include: Placebo (OTHER), Liothyronine (DRUG).
Who is sponsoring clinical trial NCT04112316?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04112316 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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