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Taurine Supplementation for Cardiomyopathy in Thalassemia (TICATS Trial)

N/A
Recruiting
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of transfusion-dependent Thalassemia being followed at the RBC clinic at TGH
Age 18 or older
Must not have
Liver iron concentration > 40 mg/g dw as measured by liver R2 MRI (FerriScan) measured within 3 months prior to randomization
Women who are currently pregnant or plan to become pregnant during the study period
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months

Summary

This trial evaluates if adding taurine to standard iron chelation therapy is better at reducing iron overload, oxidative stress & cardiac damage in β-Thalassemia patients.

Who is the study for?
This trial is for adults over 18 with transfusion-dependent Thalassemia, a specific heart condition (LVEF >50%), and certain levels of iron in the heart and liver. It's not for those with recent other trials, high liver iron, low serum ferritin, frequent transfusions or potential pregnancy.
What is being tested?
The study tests if Taurine added to standard iron removal treatment works better than the treatment alone in reducing heart damage from too much iron in patients with β-Thalassemia. Participants are randomly assigned to get either Taurine or a placebo alongside their usual therapy.
What are the potential side effects?
Potential side effects aren't specified here but could include reactions related to Taurine supplementation such as nausea or digestive issues. Standard chelation therapy side effects may also occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have transfusion-dependent Thalassemia and am being treated at the RBC clinic at TGH.
Select...
I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My liver iron concentration is high, as confirmed by a recent MRI.
Select...
I am not pregnant and do not plan to become pregnant during the study.
Select...
I have had more than 16 transfusions in the last year or need them every 3 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Cardiac iron overload
Secondary study objectives
Blood taurine level
C-reactive protein
Interleukin-6
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: TaurineExperimental Treatment1 Intervention
675mg taurine four times daily
Group II: PlaceboPlacebo Group1 Intervention
placebo four times daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Taurine
2010
Completed Phase 4
~310

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,523 Previous Clinical Trials
503,138 Total Patients Enrolled
2 Trials studying Thalassemia
92 Patients Enrolled for Thalassemia
~11 spots leftby Nov 2025
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