PACTR201902478249291已完成2 期
Effects of amlodipine on myocardial iron deposition in pediatric patients with thalassemia major
Beni suef university hospital0 个研究点目标入组 40 人开始时间: 2019年2月2日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
研究概览
简要总结
After 6 months, a significant reduction was noted in the MIC of patients receiving amlodipine (n=20), compared with the patients receiving the placebo (n=20). At baseline, the mean was 0.76±0.11 mg/g dry weight, while at 6 months, the mean was 0.51±0.07 mg/g dry weight (p< 0.001). Also, there was a significant change in the myocardial T2* after 6 months; the amlodipine increased the myocardial T2* from 40.63±5.45 ms at baseline to 43.25±5.35 ms (p< 0.001). However, amlodipine did not significantly affect the secondary outcomes by the end of the study.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 6 Year(s) 至 12 Year(s)（—）
- 性别
- All
入选标准
- •Patients eligible for enrollment at baseline were male or female aged between 6 and 18 years old with ß-Thalassemia major.
- •Potential participants had been diagnosed with thalassemia major (TM), as confirmed by the presence of microcytic hypochromic anemia and hemoglobin electrophoresis;
- •additionally, patients who had been receiving a regular blood transfusion during the last two years,
- •with a serum ferritin (SF) level more than 1000 ng /ml were also considered.
排除标准
- •Participants were excluded if they were more than 20 years old,
- •their SF was less than 1000 ng /ml,
- •they experienced heart failure (ejection fraction (EF) less than 30%),
- •they were contraindicated to undergo the magnetic resonance imaging (MRI) scan,
- •or they were expected to change their chelation therapy regimen during the next 6 months.
研究者
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