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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04291352
Recruitment Status : Unknown
Verified February 2020 by University Health Network, Toronto.
Recruitment status was:  Not yet recruiting
First Posted : March 2, 2020
Last Update Posted : March 2, 2020
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

Study Description
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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.


Condition or disease Intervention/treatment Phase
Thalassemia Major Dietary Supplement: Taurine Other: Placebo Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Triple (Participant, Care Provider, Investigator)
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.
Primary Purpose: Treatment
Official Title: Thalassemic Iron Overload Cardiomyopathy is Ameliorated by Taurine Supplementation (TICATS Study)
Estimated Study Start Date : June 1, 2020
Estimated Primary Completion Date : May 31, 2023
Estimated Study Completion Date : May 31, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Taurine

Arms and Interventions
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Arm Intervention/treatment
Experimental: Taurine
675mg taurine four times daily
 Dietary Supplement: Taurine
675mg taurine four times daily
Placebo Comparator: Placebo
placebo four times daily
 Other: Placebo
placebo four times daily


Outcome Measures
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Primary Outcome Measures :
  1. Cardiac iron overload [ Time Frame: 12 months ]
    Differences in ratio (T2* at year 1)/(T2* at baseline) between the taurine and standard chelation therapy arm


Secondary Outcome Measures :
  1. Left ventricular ejection fraction [ Time Frame: 12 months ]
    Differences in LVEF between the taurine and standard chelation therapy arm

  2. Blood taurine level [ Time Frame: 12 months ]
    Differences in blood taurine level between the taurine and standard chelation therapy arm

  3. C-reactive protein [ Time Frame: 12 months ]
    Differences in CRP between the taurine and standard chelation therapy arm

  4. Interleukin-6 [ Time Frame: 12 months ]
    Differences in IL-6 between the taurine and standard chelation therapy arm

  5. Plasma MDA [ Time Frame: 12 months ]
    Differences in Plasma MDA between the taurine and standard chelation therapy arm

  6. Reduced glutathione [ Time Frame: 12 months ]
    Differences in GSH between the taurine and standard chelation therapy arm


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Participant inclusion criteria

Participants who meet all of the following criteria will qualify for entry into the study:

  1. Diagnosis of transfusion-dependent Thalassemia being followed at the RBC clinic at TGH
  2. Age 18 or older
  3. On a stable dose of iron chelation for >30 days. Combination iron chelation regimen is allowed in the study
  4. Cardiac MRI T2* ≥8ms measured within 3 months prior to randomization.
  5. 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:

  1. 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
  2. Serum ferritin < 500 ng/mL at screening
  3. Liver iron concentration > 40 mg/g dw as measured by liver R2 MRI (FerriScan) measured within 3 months prior to randomization
  4. Signs and symptoms consistent with congestive heart failure in the opinion of the investigator
  5. As a result of medical review, physical examination or screening investigations, the investigator considers the subject unfit for the study.
  6. No fixed address
  7. Interval advent of general contraindications to MRI.
  8. Taking another investigational product within 30 days of anticipated date of randomization
  9. Women who are currently pregnant or plan to become pregnant during the study period
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04291352


Contacts
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Contact: Anneliesse Justiniano 416-340-4800 ext 6729 anneliesse.justiniano@uhn.ca
Contact: Red blood Cell Disorders Clinical Trials Program rbcd.clinicaltrials@uhn.ca

Sponsors and Collaborators
University Health Network, Toronto
More Information
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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT04291352    
Other Study ID Numbers: 18-5613
First Posted: March 2, 2020    Key Record Dates
Last Update Posted: March 2, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Undetermined at this time

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cardiomyopathies
Thalassemia
beta-Thalassemia
Iron Overload
Heart Diseases
Cardiovascular Diseases
Anemia, Hemolytic, Congenital
 Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Iron Metabolism Disorders
Metabolic Diseases