Thalassemic Iron Overload Cardiomyopathy is Ameliorated by Taurine Supplementation

Launched by UNIVERSITY HEALTH NETWORK, TORONTO · Feb 28, 2020

Keywords

ClinConnect Summary

This clinical trial is studying whether adding a supplement called taurine to standard iron chelation therapy can help reduce heart problems in patients with β-Thalassemia Major. The researchers believe that taurine may work better than just the iron chelation therapy alone by lowering the amount of iron in the heart, reducing oxidative stress (which can harm cells), and improving heart health. The study will involve 60 participants who are already receiving iron chelation therapy and will be divided into two groups: one will continue with their usual treatment, while the other will receive both the usual treatment and taurine.

To be eligible for this trial, participants must be at least 18 years old, have a diagnosis of transfusion-dependent β-Thalassemia, and have been on a stable dose of iron chelation therapy for over 30 days. They also need to have certain heart health measurements that show their heart is functioning well. Throughout the study, participants will have monthly visits to check their health and treatment safety, and their heart health will be assessed after 12 months. This trial is currently recruiting participants, and it aims to find out if taurine can make a positive difference in heart health for those living with this condition.

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Eligibility criteria

• • Participant inclusion criteria
• Participants who meet all of the following criteria will qualify for entry into the study:
• • 1. Diagnosis of transfusion-dependent Thalassemia being followed at the RBC clinic at TGH
• • 2. Age 18 or older
• • 3. On a stable dose of iron chelation for \>30 days. Combination iron chelation regimen is allowed in the study
• • 4. Cardiac MRI T2\* ≥8ms measured within 3 months prior to randomization.
• • 5. Preserved left ventricular ejection fraction (LVEF) \>50% as measured by cardiac MRI measured within 3 months prior to randomization.
• • Participant exclusion criteria
• Participants who meet any of the following criteria will be excluded from the study:
• • 1. More than 16 transfusions in the past 12 months or those who are anticipated to be on a 3 week transfusion schedule during the study period
• • 2. Serum ferritin \< 500 ng/mL at screening
• • 3. Liver iron concentration \> 40 mg/g dw as measured by liver R2 MRI (FerriScan) measured within 3 months prior to randomization
• • 4. Signs and symptoms consistent with congestive heart failure in the opinion of the investigator
• • 5. As a result of medical review, physical examination or screening investigations, the investigator considers the subject unfit for the study.
• • 6. No fixed address
• • 7. Interval advent of general contraindications to MRI.
• • 8. Taking another investigational product within 30 days of anticipated date of randomization
• • 9. Women who are currently pregnant or plan to become pregnant during the study period