Back to resultsThalassemic Iron Overload Cardiomyopathy is Ameliorated by Taurine Supplementation (TICATS)
Primary Purpose
Thalassemia Major
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Taurine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Thalassemia Major
Eligibility Criteria
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
Sites / Locations
- University Health NetworkRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Taurine
Placebo
Arm Description
675mg taurine four times daily
placebo four times daily
Outcomes
Primary Outcome Measures
Cardiac iron overload
Differences in ratio (T2* at year 1)/(T2* at baseline) between the taurine and standard chelation therapy arm
Secondary Outcome Measures
Left ventricular ejection fraction
Differences in LVEF between the taurine and standard chelation therapy arm
Blood taurine level
Differences in blood taurine level between the taurine and standard chelation therapy arm
C-reactive protein
Differences in CRP between the taurine and standard chelation therapy arm
Interleukin-6
Differences in IL-6 between the taurine and standard chelation therapy arm
Plasma MDA
Differences in Plasma MDA between the taurine and standard chelation therapy arm
Reduced glutathione
Differences in GSH between the taurine and standard chelation therapy arm
Full Information
NCT ID
NCT04291352
First Posted
February 28, 2020
Last Updated
September 30, 2023
Sponsor
University Health Network, Toronto
1. Study Identification
Unique Protocol Identification Number
NCT04291352
Brief Title
Thalassemic Iron Overload Cardiomyopathy is Ameliorated by Taurine Supplementation
Acronym
TICATS
Official Title
Thalassemic Iron Overload Cardiomyopathy is Ameliorated by Taurine Supplementation (TICATS Study)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
October 31, 2024 (Anticipated)
Study Completion Date
October 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Health Network, Toronto
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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-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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thalassemia Major
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, double-blind, randomized control trial. Subjects are randomized to receive either taurine or placebo in addition to their standard chelation regimen for a 12 month period.
Masking
ParticipantCare ProviderInvestigator
Masking Description
Both taurine and placebo powder inside the capsules are a white crystalline, odorless powder. The powder is loaded into clear, vegetarian, odorless capsules. Placebo and Investigational Product capsules will be packaged in 500 cc HDPE bottles.
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Taurine
Arm Type
Experimental
Arm Description
675mg taurine four times daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo four times daily
Intervention Type
Dietary Supplement
Intervention Name(s)
Taurine
Intervention Description
675mg taurine four times daily
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
placebo four times daily
Primary Outcome Measure Information:
Title
Cardiac iron overload
Description
Differences in ratio (T2* at year 1)/(T2* at baseline) between the taurine and standard chelation therapy arm
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Left ventricular ejection fraction
Description
Differences in LVEF between the taurine and standard chelation therapy arm
Time Frame
12 months
Title
Blood taurine level
Description
Differences in blood taurine level between the taurine and standard chelation therapy arm
Time Frame
12 months
Title
C-reactive protein
Description
Differences in CRP between the taurine and standard chelation therapy arm
Time Frame
12 months
Title
Interleukin-6
Description
Differences in IL-6 between the taurine and standard chelation therapy arm
Time Frame
12 months
Title
Plasma MDA
Description
Differences in Plasma MDA between the taurine and standard chelation therapy arm
Time Frame
12 months
Title
Reduced glutathione
Description
Differences in GSH between the taurine and standard chelation therapy arm
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anneliesse Justiniano
Phone
416-340-4800
Ext
6729
Email
anneliesse.justiniano@uhn.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Red blood Cell Disorders Clinical Trials Program
Email
rbcd.clinicaltrials@uhn.ca
Facility Information:
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anneliesse Justiniano
Phone
+1-416-715-6485
Email
RBCD.clinicaltrials@uhn.ca
First Name & Middle Initial & Last Name & Degree
Kevin Kuo, MD, MSc, FRCPC
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Undetermined at this time
Learn more about this trial
Thalassemic Iron Overload Cardiomyopathy is Ameliorated by Taurine Supplementation
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