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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 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.

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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.

Interventions

  • OTHER Placebo
  • DRUG Liothyronine

Study Locations (1)

Pennsylvania

  • PennMedicine - Philadelphia

Trial Details

FieldValue
Enrollment Target 28 participants
Start Date 2020-02-11
Est. Completion 2023-10-31
Phase Phase 1

Sponsor

University of Pennsylvania

1,423 total trials

What the Registry Record Tells You About NCT04112316

The ClinicalTrials.gov registry entry for NCT04112316 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 538-participant average among 5 other Heart Failure With Reduced Ejection Fraction (HFrEF) trials with a reported enrollment target (95% lower). The listed sponsor is University of Pennsylvania, which has 1,423 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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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