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

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ClinicalTrials.gov Identifier: NCT04291352
Recruitment Status : Not yet recruiting
First Posted : March 2, 2020
Last Update Posted : March 2, 2020
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

Tracking Information
First Submitted Date  ICMJE February 28, 2020
First Posted Date  ICMJE March 2, 2020
Last Update Posted Date March 2, 2020
Estimated Study Start Date  ICMJE June 1, 2020
Estimated Primary Completion Date May 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 28, 2020)		 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 28, 2020)
  • Left ventricular ejection fraction [ Time Frame: 12 months ]
    Differences in LVEF between the taurine and standard chelation therapy arm
  • Blood taurine level [ Time Frame: 12 months ]
    Differences in blood taurine level between the taurine and standard chelation therapy arm
  • C-reactive protein [ Time Frame: 12 months ]
    Differences in CRP between the taurine and standard chelation therapy arm
  • Interleukin-6 [ Time Frame: 12 months ]
    Differences in IL-6 between the taurine and standard chelation therapy arm
  • Plasma MDA [ Time Frame: 12 months ]
    Differences in Plasma MDA between the taurine and standard chelation therapy arm
  • Reduced glutathione [ Time Frame: 12 months ]
    Differences in GSH between the taurine and standard chelation therapy arm
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Thalassemic Iron Overload Cardiomyopathy is Ameliorated by Taurine Supplementation
Official Title  ICMJE Thalassemic Iron Overload Cardiomyopathy is Ameliorated by Taurine Supplementation (TICATS Study)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Thalassemia Major
Intervention  ICMJE
  • Dietary Supplement: Taurine
    675mg taurine four times daily
  • Other: Placebo
    placebo four times daily
Study Arms  ICMJE
  • Experimental: Taurine
    675mg taurine four times daily
    Intervention: Dietary Supplement: Taurine
  • Placebo Comparator: Placebo
    placebo four times daily
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: February 28, 2020)		 60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 31, 2023
Estimated Primary Completion Date May 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Anneliesse Justiniano 416-340-4800 ext 6729 anneliesse.justiniano@uhn.ca
Contact: Red blood Cell Disorders Clinical Trials Program rbcd.clinicaltrials@uhn.ca
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04291352
Other Study ID Numbers  ICMJE 18-5613
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: Undetermined at this time
Current Responsible Party University Health Network, Toronto
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University Health Network, Toronto
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University Health Network, Toronto
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP