Ivabradine to Prevent Anthracycline-induced Cardiotoxicity: a Prospective Randomized Open Label Clinical Trial
试验速览
- 阶段
- 3 期
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Change in left venticular dysfunction by global longitudinal strain (GLS).
研究概览
简要总结
The aim of this study is to investigate protective effects of ivabradine in adult cancer patients undergoing anthracycline-based chemotherapy.
详细描述
Cancer treatment with anthracyclines may cause heart damage and can lead to heart failure. There are drugs which may protect against cardiotoxic effects of anthracyclines (renin-angiotensin inhibitors and beta blockers), but they are not tolerated due to hypotension. Ivabradine is heart rate lowering drug without effect on blood pressure which was approved for treatment of angina pectoris and heart failure. The aim of this study is to investigate protective effects of ivabradine in cancer patients undergoing anthracycline-based chemotherapy.
Ivabradine selectively inhibits If currents in the sinus node and prolongs the duration of spontaneous depolarization. That controls the heart's contractions and regulates the heart rate. Additionally, ivabradine might preserve myocardial function and contractility without effect on blood pressure. Ivabradine was approved for symptomatic treatment of chronic stable angina pectoris and chronic heart failure.
The aim of this study is to investigate protective effects of ivabradine in adult cancer patients undergoing anthracycline-based chemotherapy.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •cancer patients undergoing anthracyclines based chemotherapy;
- •heart rate (HR) > 70 times per minute;
- •Written informed consent.
排除标准
- •Contraindications for ivabradine administration;
- •HR<70 times per minute;
- •Incapability to complete informed consent;
- •Severe valve disease;
- •Left ventricular ejection fraction (LVEF)≤ 30 %;
- •Other severe conditions;
- •Poor echogenicity.
研究组 & 干预措施
Ivabradine
Patients will receive ivabradine just before anthracycline chemotherapy, 5 mg per oral twice daily, until the last chemotherapy session
干预措施: Ivabradine (Drug)
结局指标
主要结局
Change in left venticular dysfunction by global longitudinal strain (GLS).
时间窗: 1, 3 and 6 months
Change in global longitudinal strain (GLS) at least by 3%.
次要结局
- Incidence of myocardial injury according to levels of high-sensitivity cardiac troponin T and NT-proBNP(1, 3 and 6 months)
- Incidence of left ventricular systolic and diastolic dysfunction by 2D and 3D echocardiography.(1, 3 and 6 months)
研究者
Sigita Aidietiene
Assoc. Prof.
Vilnius University