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Effects of Triiodothyronine (T3) in Ischemic Heart Failure

NCT05384847 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-06-26

No results posted yet for this study

Summary

This study aims to determine whether giving triiodothyronine (T3), a thyroid hormone, is safe and helps improve symptoms and signs of heart failure.

The study is divided into 2 phases. In the first phase, participants have a 50-50 chance of receiving the study drug. Participants who are enrolled to receive the study drug will be admitted to the General Clinical Research Center (GCRC) for 5 days for oral thyroid hormone treatment and monitoring. They will have 4 additional follow-up visits over the next year. Participants who are not enrolled to receive the study drug will not be admitted but will have similar follow-up visits in the outpatient setting. Participants who do not receive the drug in Phase I will have the opportunity to enroll in Phase II of the study where everyone will receive the thyroid hormone treatment.

If this study finds that patients have improved heart function after treatment with thyroid hormone without unacceptable side effects, this could result in a new treatment for patients with heart failure.

Conditions

Interventions

DRUG

Thyroid hormone T3

Participants will be admitted to the General Clinical Research Center (GCRC) for up to 5 days and will receive study medication twice a day. Participants will receive oral T3 under the supervision of the Principal Investigator or qualified co-investigators at the GCRC. The study drug will be given within 30 days after enrollment.

OTHER

Control Group

The control group will have testing and study procedures as per protocol but will not be admitted to the General Clinical Research Center (GCRC) and will not receive the study medication. After completion of phase I, participants will be permitted to enroll in Phase II.

Sponsors & Collaborators

  • Emory University

    lead OTHER

Principal Investigators

  • Arshed A. Quyyumi, MD · Emory University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-02
Primary Completion
2026-05-31
Completion
2026-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05384847 on ClinicalTrials.gov