The Effect of Cardioprotective Medications on Chemotherapy-Induced Cardiotoxicity in Childhood Acute Leukemia
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Left Ventricular Ejection Fraction (LVEF)
研究概览
简要总结
The aim of the present study is to evaluate the protective impact of cardioprotective medications on the chemotherapy- induced cardiotoxicity.
详细描述
The goal of this interventional study is to evaluate the protective impact of Angiotensin-converting enzyme (ACE) inhibitors versus β-blockers on the cardiotoxicity profile of pediatric patients with acute leukemia. The impact is measured by evaluation of left ventricular ejection fraction (LVEF) by 2D echocardiography at baseline and at the end of Induction phase (42 days).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willingness of the legal representative of research participant to participate in the study by giving "informed consent."
- •Ability to take oral medication.
- •Age 2-18 years at the time of diagnosis.
排除标准
- •Documented allergy to cardioprotective medications
研究组 & 干预措施
ACEIs
0.3 mg/kg/dose every 8 hours orally by either a caregiver or caring nurse.
干预措施: ACE Inhibitors (Drug)
β-blockers
0.05 mg/kg/dose every 12 hours orally by either a caregiver or caring nurse
干预措施: β -Blockers (Drug)
结局指标
主要结局
Change in Left Ventricular Ejection Fraction (LVEF)
时间窗: LVEF will be measured at Baseline and at the end of Induction Phase (42 Days)
he LVEF will be measure by 2D Echocardiography at baseline and at the end of Induction Phase (42 Days)
次要结局
未报告次要终点
研究者
keristin nazir
Teaching Assistant
Ain Shams University