Status:
UNKNOWN
Thalassemic Iron Overload Cardiomyopathy is Ameliorated by Taurine Supplementation
Lead Sponsor:
University Health Network, Toronto
Conditions:
Thalassemia Major
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Hypothesis: Taurine, in combination with standard iron chelation therapy, is more effective than chelation therapy alone in reducing cardiac iron overload, oxidative stress and cardiac damage in β-Tha...
Eligibility Criteria
Inclusion
- Participant inclusion criteria
- Participants who meet all of the following criteria will qualify for entry into the study:
- Diagnosis of transfusion-dependent Thalassemia being followed at the RBC clinic at TGH
- Age 18 or older
- On a stable dose of iron chelation for \>30 days. Combination iron chelation regimen is allowed in the study
- Cardiac MRI T2\* ≥8ms measured within 3 months prior to randomization.
- 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:
- 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
- Serum ferritin \< 500 ng/mL at screening
- Liver iron concentration \> 40 mg/g dw as measured by liver R2 MRI (FerriScan) measured within 3 months prior to randomization
- Signs and symptoms consistent with congestive heart failure in the opinion of the investigator
- As a result of medical review, physical examination or screening investigations, the investigator considers the subject unfit for the study.
- No fixed address
- Interval advent of general contraindications to MRI.
- Taking another investigational product within 30 days of anticipated date of randomization
- Women who are currently pregnant or plan to become pregnant during the study period
Exclusion
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04291352
Start Date
June 1 2020
End Date
October 31 2025
Last Update
October 3 2023
Active Locations (1)
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1
University Health Network
Toronto, Ontario, Canada, M5G 2C4