Using thyroid hormone T3 to improve heart function in patients with ischemic heart failure

Effects of Triiodothyronine (T3) in Ischemic Heart Failure

This study is testing if a thyroid hormone called T3 can help improve heart function in people with ischemic heart failure who are already on standard treatments.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Emory University (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 2 sites (Atlanta, Georgia and 1 other locations)
• Trial ID: NCT05384847 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the safety and efficacy of triiodothyronine (T3), a thyroid hormone, in improving symptoms and signs of ischemic heart failure. The study is conducted in two phases, where participants in the first phase have a 50-50 chance of receiving the treatment, while those in the second phase will all receive T3. Participants will be monitored closely during a 5-day inpatient stay and through follow-up visits over the next year. The goal is to determine if T3 can enhance heart function in patients already on standard heart failure therapies.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-80 with ischemic heart failure and a left ventricular ejection fraction of 40% or less, who are stable and receiving standard heart failure therapies.

Not a fit: Patients with non-ischemic heart failure or those with a left ventricular ejection fraction greater than 40% may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with ischemic heart failure, potentially improving their heart function and overall quality of life.

How similar studies have performed: While the use of thyroid hormones in heart failure is a novel approach, similar studies have shown promise in improving cardiac function, indicating potential for success.

Eligibility criteria

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 other surgery), carotid artery or other large vessel surgery, or cardiac resynchronization therapy (CRT) implant within the past 3 months;
* Planned revascularization within 6 months;
* History of heart transplantation, use of ventricular assist device (VAD) or preparation for heart transplantation, VAD;
* 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;
* Systolic blood pressure \< 90 mmHg or \> 160 mmHg;
* Blood K+ \< 3.2 mmol/L or \> 5.5 mmol/L;
* Women of childbearing age who are planning to become pregnant within 2 years, and pregnant or lactating women;
* Patients whose survival time is expected to be less than 6 months as judged by the investigator;
* Those who have participated in any drug clinical trial within the previous 3 months;
* 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.
* 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;

Where this trial is running

Atlanta, Georgia and 1 other locations

• Emory University Hospital (EUH) — Atlanta, Georgia, United States (Recruiting)
• Emory University Hospital Clinical Research Network — Atlanta, Georgia, United States (Recruiting)

Study contacts

• Principal investigator: Arshed A. Quyyumi, MD — Emory University
• Study coordinator: Arshed A. Quyyumi, MD

Conditions Heart Failure; Ischemic Heart Failure; NYHA Class II-III; Implantable Cardioverter Defibrillator