Amlodipine in the Prevention and Treatment of Iron Overload in Patients With Thalassemia Major: a Randomized, Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Myocardial T2* values (msec)
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 60 patients with thalassemia major: 30 will receive amlodipine and 30 will serve as controls receiving placebo in a randomized double-blind fashion. Patients will be monitored through one year. Monitoring will occur through the measurement of blood ferritin as well as live and heart T2* by MRI initially, at 6 and 12 months.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with thalassemia major with at least 6 years of age undergoing iron chelation therapy.
- •No anticipated changes in chelation regimen for the next 12 months
- •Completed and signed Informed Consent
排除标准
- •Advanced class III/IV heart failure or LVEF < 0.35% (by MRI)
- •Formal contra-indications to MRI (pacemakers, cerebral aneurysm metal clips, etc).
- •Advanced heart AV block
研究组 & 干预措施
Starch pill
Placebo
干预措施: Amlodipine (Drug)
Amlodipine
Amlodipine 5mg QD
干预措施: Amlodipine (Drug)
结局指标
主要结局
Myocardial T2* values (msec)
时间窗: 6 and 12 months
T2\* values represent the amount of iron in the myocardial and is quantified in msec and measured by cardiovascular magnetic resonance
次要结局
- Liver T2* values (msec)(6 and 12 months)
- Serum ferritin levels(6 and 12 months)
- left ventricle volumes and function(6 and 12 months)
研究者
Juliano de Lara Fernandes
Physician Researcher
University of Campinas, Brazil