Triiodothyronine (T3) for Heart Failure
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it mentions that patients on other beta-blockers will be switched to metoprolol succinate for 3 weeks. It's best to discuss your specific medications with the study team.
What evidence supports the effectiveness of the drug Triiodothyronine (T3) for heart failure?
Research suggests that Triiodothyronine (T3) may improve heart function in patients with heart conditions, as studies have shown it can enhance heart performance and reduce heart damage in patients with heart attacks. However, more research is needed to confirm its benefits specifically for heart failure.12345
Is Triiodothyronine (T3) generally safe for use in humans?
Triiodothyronine (T3) has been studied for various conditions, and while low doses are generally well-tolerated, higher doses can increase heart rate and the risk of heart rhythm problems and sudden death. Long-term use of T3 has been associated with increased risks of heart failure and stroke, especially in patients with a history of thyroid cancer.16789
How does the drug Triiodothyronine (T3) differ from other treatments for heart failure?
Triiodothyronine (T3) is unique in treating heart failure because it targets low levels of T3, a thyroid hormone often reduced in heart failure patients, to improve heart function and metabolism. Unlike standard heart failure treatments, T3 specifically addresses thyroid hormone imbalances, which can enhance cardiac performance and potentially improve survival rates.168910
Research Team
Arshed A. Quyyumi, MD
Principal Investigator
Emory University
Eligibility Criteria
This trial is for adults aged 18-80 with ischemic heart failure and a left ventricular ejection fraction (LVEF) ≤ 40%. They must be stable, on standard heart failure therapies including metoprolol succinate, and have an ICD or CRT-D device. Excluded are those with recent cardiac events, other drug trials within 3 months, endocrine disorders like thyroid disease, severe blood pressure issues, liver or kidney dysfunction, severe neurological disorders, life-limiting cancer history or planning major surgery.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Phase IA Treatment
Participants receive ascending doses of T3 (5 µg orally twice daily for the first 2 days and 10 µg orally twice daily for the next 3 days) with monitoring
Phase IB Treatment
Participants receive adjusted doses of T3 (10 µg orally twice daily on day 1 and 20 µg twice daily from day 2 to 5) based on safety data
Phase II Treatment
Participants receive a stable dose of T3 (20 µg orally twice daily for 5 days) after completing Phase I
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Triiodothyronine (T3)
Triiodothyronine (T3) is already approved in European Union, United States for the following indications:
- Hypothyroidism
- Heart failure with low-T3 syndrome
- Hypothyroidism
- Heart failure with low-T3 syndrome
Find a Clinic Near You
Who Is Running the Clinical Trial?
Emory University
Lead Sponsor