EUCTR2017-004618-24-IT进行中(未招募)1 期
Evaluation of CardioprOtection by the use of betablocker Nebivolol in paTients with bReast cancer Or diffuse Large B cell lymphoma undergoing chemotherapy with anthracyclines: a randomized controlled trial. - Evaluation of CardioprOtection by the use of betablocker Nebivolol in paTients with bReast cancer Or
IRCCS ISTITUTO CLINICO HUMANITAS0 个研究点目标入组 80 人开始时间: 2018年9月14日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Age =18 years
- •2.Established histological diagnosis of BC or DLBCL
- •3.Planned first-line chemotherapy with anthracyclines
- •4.LVEF =55% (assessed by echocardiography)
- •5.Ability to provide informed consent
- •6.For women of childbearing potential a negative serum pregnancy is required before the inclusion in the study
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 1
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •1.Known intolerance/contraindications to betablocker therapy
- •2.Known hypersensitivity to nebivolol or any of the excipients
- •3.History of coronary artery disease
- •4.History of cardiomyopathy
- •5.History of heart failure
- •6.Ongoing treatment with betablockers for other indications
- •7.Heart rate <60 beats per minute
- •8.Arterial blood pressure <100/60 mmHg
- •9.Contraindications to undergo MRI (e.g., non compatible pacemakers or metallic prosthesis)
- •10.Pregnancy or lactation
- •11.Currently participating in another trial
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