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

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement, Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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.

Locations
Other Locations
Canada
University Health Network
RECRUITING
Toronto
Contact Information
Primary
Anneliesse Justiniano
anneliesse.justiniano@uhn.ca
416-340-4800
Backup
Red blood Cell Disorders Clinical Trials Program
rbcd.clinicaltrials@uhn.ca
Time Frame
Start Date: 2020-06-01
Estimated Completion Date: 2025-10-31
Participants
Target number of participants: 60
Treatments
Experimental: Taurine
675mg taurine four times daily
Placebo_comparator: Placebo
placebo four times daily
Sponsors
Leads: University Health Network, Toronto

This content was sourced from clinicaltrials.gov