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临床试验/NCT04291352
NCT04291352招募中不适用

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

University Health Network, Toronto2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
2
主要终点
Cardiac iron overload

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

盲法说明

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.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Cardiac iron overload

时间窗: 12 months

Differences in ratio (T2\* at year 1)/(T2\* at baseline) between the taurine and standard chelation therapy arm

次要结局

  • C-reactive protein(12 months)
  • Reduced glutathione(12 months)
  • Left ventricular ejection fraction(12 months)
  • Blood taurine level(12 months)
  • Plasma MDA(12 months)
  • Interleukin-6(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kevin H.M. Kuo, MD, MSc, FRCPC

Principal Investigator

University Health Network, Toronto

研究点 (2)

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