Triiodothyronine (T3) for Heart Failure

Phase 1 & 2

Recruiting

Led By Arshed A. Quyyumi, MD

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up after 1 week of study drug administration up to 12 months

Summary

This trial is testing whether the thyroid hormone T3 is safe and effective in treating heart failure. Participants will be randomly assigned to either receive the hormone or not, and then monitored for a year. If successful, this could result in a new treatment for heart failure.

Who is the study for?

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.

What is being tested?

The study tests if Triiodothyronine (T3), a thyroid hormone can safely improve symptoms of ischemic heart failure. Participants have equal chances to receive T3 or no treatment initially; non-treated in Phase 1 may get T3 in Phase 2. The first group stays at the GCRC for monitoring over five days plus follow-ups; the second has outpatient visits.

What are the potential side effects?

Potential side effects of T3 treatment could include abnormal heart rhythms due to hormonal changes affecting the cardiovascular system. Other general side effects might involve alterations in metabolism leading to weight changes, temperature sensitivity issues and potential impact on mood.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ after 1 week of study drug administration up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~after 1 week of study drug administration up to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and after 1 week of study drug administration up to 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes in the presence of clinical arrhythmias

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

Secondary study objectives

Change in 6-minute walk distance (6MWD)

Change in Kansas City Cardiomyopathy Questionnaire (KCCQ)

Change in left ventricular ejection fraction (LVEF)

+2 more

Other study objectives

Changes Left ventricular end-systolic volume index (LVESVI) and end-diastolic volume index (LVEDVI)

Changes in longitudinal and circumferential strain by speckle-tracking echocardiography

Changes in the LV posterior wall (LVPW) thickness by speckle-tracking echocardiography

+4 more

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Experimental Phase IIExperimental Treatment1 Intervention

Patients who were enrolled in the open-label control group of Phase I and who have completed the 3-month follow-up will be permitted to enroll in Phase II. This Phase will start treatment after completion of Phase I and approval from the Data and Safety Monitoring Board (DSMB) to proceed with a single cohort that will receive a stable dose of the study drug (20 µg T3 orally twice daily for 5 days).

Group II: Experimental Phase IBExperimental Treatment1 Intervention

In Phase IB, dose adjustments will be calculated while accounting for laboratory and safety data from the first two participants (Phase IA) for the remaining 3 participants within the treatment arm of Phase I. Participants 3 to 5 will receive 10 µg T3 orally twice daily on day 1 and 20 µg T3 twice daily from day 2 to 5.

Group III: Experimental Phase IAExperimental Treatment1 Intervention

In Phase IA two participants (1 and 2) will receive ascending dose levels of the study drug (5 µg T3 orally twice daily for the first 2 days and 10 µg T3 orally twice daily for the next 3 days).

Group IV: Control Group-Phase IA and IBPlacebo Group1 Intervention

The control group will have testing as the experimental group but will not be given any medications.

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