Thalassemic Iron Overload Cardiomyopathy is Ameliorated by Taurine Supplementation (NCT04291352) | Clinical Trial Compass
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Thalassemic Iron Overload Cardiomyopathy is Ameliorated by Taurine Supplementation
Canada60 participantsStarted 2020-06-01
Plain-language 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-Thalassemia.
Protocol: Sixty subjects with transfusion dependent β-Thalassemia receiving deferasirox iron chelation therapy will be recruited and randomized in a 1:1 ratio to either (1) placebo and continuation of their iron chelation or (2) a combination of iron chelation plus taurine. Transfusion and safety visits will be scheduled monthly with clinical/biochemical assessment visits every three months. The efficacy of taurine combined with standard chelation therapy will be assessed at baseline and 12 months posttreatment by both cardiac T2\*MRI, and cardiac function. The recruitment period is projected to be 12 months from initiation.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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