NCT05384847CompletedPhase 1
Effects of Triiodothyronine (T3) in Ischemic Heart Failure
Source: ClinicalTrials.gov · Last updated 4 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 14 (actual)
- First submitted
- 29 Apr 2022
- Start date
- 2 Dec 2022
- Primary completion date
- 1 Oct 2025
- Lead sponsor
- Emory University
- Diseases
- Heart failure
- NCT number
- NCT05384847
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 14
- From 2 Dec 2022 to the primary completion date, 1 Oct 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Those who have participated in any drug clinical trial within the previous 3 months;
Other illness
- 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;
- Angina pectoris, cerebrovascular accident, myocardial infarction, revascularization (PCI or other surgery), carotid artery or other large vessel surgery, or cardiac resynchronization therapy (CRT) implant within the past 3 months;
- History of heart transplantation, use of ventricular assist device (VAD) or preparation for heart transplantation, VAD;
- Severe neurological disorders (Alzheimer's disease, progressive parkinsonism);
- The subjects with a history of cancer that limits life expectancy to \<1 year;
- Endocrine disorders include thyroid disease, thyroid replacement therapy, pheochromocytoma, thyromegaly, etc.
Lab values
- LVEF \> 40%;
- Liver dysfunction (bilirubin or alkaline phosphatase \> 2 times the upper limit of normal (ULN), aspartate aminotransferase or alanine aminotransferase \> 3 times the upper limit of normal), estimated glomerular filtration rate (eGFR) calculated using the Modification of Diet in Renal Disease Study (MDRD) method \< 30 ml/min/1.73 m2;
- Blood K+ \< 3.2 mmol/L or \> 5.5 mmol/L;
Age
- Women of childbearing age who are planning to become pregnant within 2 years, and pregnant or lactating women;
Other
- Unremitting atrial fibrillation during the screening period or clinically significant ventricular tachycardia (on ICD interrogation);
- Recent admission (1 month) for acute decompensated HF;
- Planned revascularization within 6 months;
- Systolic blood pressure \< 90 mmHg or \> 160 mmHg;
- Patients whose survival time is expected to be less than 6 months as judged by the investigator;
- The subject, in the judgment of the Investigator, is unable to complete the study or to comply with the requirements of the study (for administrative or other reasons);
- Prisoners;
- Adults unable to consent;
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Emory University Hospital (EUH) Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Emory University Hospital Clinical Research Network Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.