Ivabradine to Prevent Anthracycline-induced Cardiotoxicity: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Ventricular function
研究概览
简要总结
Anthracyclines are associated with cardiotoxic effects. Previous studies suggest that enalapril, and or carvedilol, protect against cardiovascular effects of these drugs.
Ivabradine selectively reduces heart rate through inhibition of the cardiac pace maker IF channel, thus prolonging the duration of spontaneous depolarization in the sinus node. Additionally, ivabradine might preserve myocardial perfusion without negative inotropic effect and probably maintain cardiac contractility despite the reduction of heart rate.
Ivabradine has been shown to improve outcome in patients with heart failure and angina. The aim of this study is to evaluate whether ivabradine might prevent anthracycline-induced cardiotoxicity.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-year-old or older;
- •Cancer diagnosis;
- •Chemotherapy with anthracycline;
- •Written informed consent
排除标准
- •Chronic Kidney Disease (Creatinine clearance inferior to 30mL/min/1.73m2)
- •Bradycardia (heart rate less than 60 beats per minute)
- •Atrial fibrilation;
- •Previous diagnosis of heart failure;
- •Pregnancy;
- •History of previous hypersensibility to the study drug;
- •Participating in another study protocol.
研究组 & 干预措施
Ivabradine
Patients will receive ivabradine just before anthracycline chemotherapy, 5 mg per oral twice daily, until one month after the last chemotherapy session.
干预措施: Ivabradine (Drug)
Placebo
Patients will receive placebo just before anthracycline chemotherapy, one capsule per oral twice daily, until one month after the last chemotherapy session.
干预措施: Placebo (Drug)
结局指标
主要结局
Ventricular function
时间窗: 365 days after randomization
Reduction in global longitudinal strain of at least 10% (GLS)
次要结局
- Incidence of myocardial injury(365 days after randomization)
- Ventricular function(180 days after randomization)
- Left ventricular dysfunction(365 days after randomization)
- Composite endpoint of mortality or major cardiovascular outcomes(365 days after randomization)
- Diastolic dysfunction(365 days after randomization)
研究者
Ludhmila Abrahão Hajjar
Clinical director of the Instituto do Coracao, Faculdade de Medicina
University of Sao Paulo