Role of Statin Therapy in Prevention of Anthracycline-Induced Cardiotoxicity
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Incidence of cancer therapy related cardiac dysfunction among the two groups
研究概览
简要总结
This study aims at evaluating the role of Atorvastatin in prevention of Anthracycline induced cardiotoxicity
详细描述
The study participants are female patients with breast cancer receiving Anthracycline based chemotherapy.
They will be divided into 2 groups , the first group will receive 40 mg oral atorvastatin through out the study , while the other group will receive a placebo.
Full echocardiographic study including 3D echocardiography will be done to all patients before starting their chemotherapy and after 6 months.
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
- Single (Participant)
盲法说明
Single blind
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients diagnosed with histology proven breast cancer with an indication to primary systemic therapy or adjuvant regimens based on anthracyclines
排除标准
- •Patients with impaired LV systolic function (EF below 50%)
- •Patients with severe valvular heart disease
- •Patients previously diagnosed with coronary artery disease
- •Patients with baseline elevated liver enzymes
- •Patients with prior chemotherapy or radiation therapy
- •Pregnant females
研究组 & 干预措施
Study Group
Fifty female patients diagnosed with breast cancer receiving Anthracycline based chemotherapy
干预措施: Atorvastatin 40 Mg Oral Tablet (Drug)
Control Group
Fifty female patients diagnosed with breast cancer receiving Anthracycline based chemotherapy
干预措施: Placebo (Other)
结局指标
主要结局
Incidence of cancer therapy related cardiac dysfunction among the two groups
时间窗: Six months
cancer therapy related cardiac dysfunction defined as drop in ejection fraction more than 10% and to a value below 53% assessed by 3D echocardiography
次要结局
- Changes in left ventricular volumes assessed by 3D echocardiography among the two groups(Six months)
- Changes in left ventricular ejection fraction assessed by 3D echocardiography among the two groups(Six months)
- Changes in left ventricular diastolic function among the two groups(Six months)
研究者
Ahmed Lotfy Mohamed
Principal Investigator
Ain Shams University