NCT04291352

Thalassemic Iron Overload Cardiomyopathy is Ameliorated by Taurine Supplementation

Thalassemic Iron Overload Cardiomyopathy is Ameliorated by Taurine Supplementation (TICATS Study)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Thalassemia Major

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Taurine	675mg taurine four times daily
OTHER	Placebo	placebo four times daily

Timeline

• Start date: 2020-06-01
• Primary completion: 2024-10-31
• Completion: 2025-10-31
• First posted: 2020-03-02
• Last updated: 2023-10-03

Locations

1 site across 1 country: Canada