Amlodipine Use in the Prevention and Treatment of Iron Overload in Patients With Thalassemia Major
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Myocardium T2*
研究概览
简要总结
This study aims to investigate the use of amlodipine, a drug that blocks the uptake of calcium into cells, in the prevention and treatment of iron overload in patients with thalassemia major. Since iron uses the same calcium channels to enter the heart, pancreas and other organs, blocking these channels might help to prevent the accumulation of iron in these tissues. The study will follow 10 patients with thalassemia major: 5 will openly receive amlodipine and 5 will serve as controls, not receiving any additional drugs. Patients will be monitored through one year with an additional year of follow up after the group using amlodipine stops its use. Monitoring will occur through the measurement of blood ferritin as well as live and heart T2* by MRI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with thalassemia major over 6 years of age in use of iron chelating therapy.
排除标准
- •pregnancy;
- •advanced heart failure with NYHA III/IV or LVEF < 35%;
- •formal contra-indications to an MRI study;
- •patient with advanced heart block.
研究组 & 干预措施
Amlodipine
amlodipine 5mg qd
干预措施: Amlodipine (Drug)
Controls
placebo
干预措施: Amlodipine (Drug)
结局指标
主要结局
Myocardium T2*
时间窗: 12 months
Heart T2\* by MRI at 12 months
次要结局
- Serum ferritin(24 months)
- Liver T2*(24 months)
- Left ventricle ejection fraction(24 months)
- Myocardium T2*(6-18-24 months)
- Heart volumes(24 months)
研究者
Juliano de Lara Fernandes
Research Physician
University of Campinas, Brazil