CompletedPhase 1

Effects of Triiodothyronine (T3) in Ischemic Heart Failure

United States14 participantsStarted 2022-12-02

Plain-language summary

This study aims to determine whether giving triiodothyronine (T3), a thyroid hormone, is safe and helps improve symptoms and signs of heart failure. 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. If this study finds that patients have improved heart function after thyroid hormone treatment without unacceptable side effects, it could lead to a new treatment for patients with heart failure.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Aged 18-80 years, male or female; * Confirmed diagnosis of ischemic HF with left ventricular ejection fraction (LVEF) ≤ 40% (measured by echocardiography within 1 month of Screening); * Stable symptoms; NYHA class II-III without recent admission (1 month) for acute decompensation; * Receiving guideline-based standard HF therapies at the maximum tolerated doses for \>1 month. Patients on other beta-blockers will be switched to metoprolol succinate at equivalent doses for 3 weeks. * Presence of ICD for \>1 month or implantable cardiac resynchronization therapy defibrillator (CRT-D) for \>3 months * Understand and sign the informed consent form. Exclusion Criteria: * LVEF \> 40%; * Unremitting atrial fibrillation during the screening period or clinically significant ventricular tachycardia (on ICD interrogation); * Non-ischemic HF including hypertrophic cardiomyopathy, peripartum or chemotherapy-induced cardiomyopathy, other non-ischemic cardiomyopathies, constrictive pericarditis, significant and uncorrected valvular heart disease (severe regurgitation or severe stenosis or valvular disease requiring surgery), congenital heart disease, primary pulmonary hypertension or secondary severe pulmonary hypertension (≥ 70 mmHg); large pericardial or pleural effusions; right heart failure due to lung disease; * Recent admission (1 month) for acute decompensated HF; * Angina pectoris, cerebrovascular accident, myocardial infarction, revascularization (PCI or othe…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Changes in the presence of clinical arrhythmias

Timeframe: Baseline, Days 1*, 2*, 3*, 4*, 5*, 6 weeks, 3 months, 6 months, 12 months

The number of participants with Angina, acute coronary syndrome, death during the first week

Timeframe: During the first week of treatment period

Trial details

NCT IDNCT05384847

SponsorEmory University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-10-01

View on ClinicalTrials.gov More Heart Failure trials