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临床试验/NCT00292526
NCT00292526已完成4 期

Prevention of Chemotherapy-induced Cardiotoxicity in High-risk Patients

European Institute of Oncology1 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2000年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
114
试验地点
1
主要终点
Incidence of chemotherapy-induced cardiotoxicity

研究概览

简要总结

In cancer patients, the increase of troponin I soon after chemotherapy is a strong predictor of left ventricular dysfunction and poor cardiologic outcome. This information provides a rationale for the development of prophylactic strategies directed against chemotherapy-induced cardiotoxicity (CTIC). Activation of the renin-angiotensin system has been proved to be involved in the development and progression of cardiac dysfunction in several clinical settings, and has been suggested to have a role in the occurrence of CTIC. We investigated the role of treatment with ACE-inhibitors in the prevention of CTIC in high-risk cancer patients.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Consecutive patients undergoing high-dose chemotherapy showing early release of Troponin I

排除标准

  • Contraindication to ACE-inhibitors
  • On-going therapy with beta-blockers, ACE-inhibitors, angiotensin-receptors blockers

研究组 & 干预措施

enalapril arm

Experimental

treatment with enalapril

干预措施: Enalapril (Drug)

结局指标

主要结局

Incidence of chemotherapy-induced cardiotoxicity

时间窗: 12 month period

次要结局

  • Major adverse cardiac events, including death.(12 month period)

研究者

发起方
European Institute of Oncology
申办方类型
Other
责任方
Sponsor

研究点 (1)

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