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临床试验/NCT02440620
NCT02440620已完成不适用

Cardiac Toxicity in Medical Treatment of Breast Cancer

Odense University Hospital1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2014年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
45
试验地点
1
主要终点
Global longitudinal strain by two dimentional speckle tracking.

研究概览

简要总结

This study will describe the epidemiology including prognosis of heart failure related to treatment with anthracycline and trastuzumab for breast cancer.

In a prospective study Human Epidermal Growth Factor Receptor 2 (HER2) positive breast cancer patients scheduled for trastuzumab treatment at Odense University Hospital, will be offered advanced echocardiographic examination, test of bio-markers and genetic markers for the purpose of investigating if early identification of patients in particular risk of developing heart failure is feasible.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Diagnosis of HER2 positive breast cancer
  • Adjuvant treatment with trastuzumab

排除标准

  • Left ventricle ejection fraction (LVEF) <50%
  • Chronic or persistent atrial fibrillation
  • History of moderate or severe valvular heart disease.

结局指标

主要结局

Global longitudinal strain by two dimentional speckle tracking.

时间窗: Change in outcome from initiation of trastuzumab treatment and after 3,6, and 9 month.

Ratio between the mitral E velocity and early diastolic maximum global strain rate (E/SRE).

时间窗: Change in outcome from initiation of trastuzumab treatment and after 3,6, and 9 month.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ann Banke

MD, Ph.d.-student

Odense University Hospital

研究点 (1)

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