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临床试验/NCT03842917
NCT03842917已完成不适用

SAlt Diet and Various Biomarkers Effects on Blood Pressure and Proteinuria During Inhibition of VEGF)

University Hospital, Tours3 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2019年4月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
26
试验地点
3
主要终点
Home blood pressure measurement

研究概览

简要总结

Bevacizumab is an anti-angiogenic treatment used to treat various solid cancers. Previous studies have shown that this treatment may have adverse effects like hypertension and proteinuria.

This is an exploratory study aiming to better understand the relationship between various biomarkers and blood pressure changes and proteinuria measured for 4 to 6 weeks after the first infusion of anti-VEGF therapy with bevacizumab.

详细描述

Participants will be invited to participate to this research study by their oncologist within 1 to 2 weeks before starting bevacizumab treatment, as part of standard treatment. They will finish the research at the end of the third infusion of bevacizumab.

Patients will perform a home blood pressure self-measurement over three days and will collect urine over 24 hours prior to the start of each bevacizumab infusion at cycles 1, 2 and 3. Blood pressure measurements will also be performed during each bevacizumab infusion and blood tests will be performed before each infusion to measure the following biomarkers:

  • Salt consumption as estimated by 24-hour natriuresis measured before each of the first 3 infusions
  • 24 hours aldosterone excretion measured before the first and third infusions
  • plasma methoxylated derivatives measured before the first and third infusions
  • NTproBNP measured before the first and third infusions
  • 24 hours urinary free cortisol measured before the first and third infusions
  • bevacizumab trough concentration measured before the first three bevacizumab infusion

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

  • Adult patient
  • With a solid cancer for which a treatment with bevacizumab (Avastin®) is indicated in accordance with its marketing authorization

排除标准

  • Renal cancer
  • Recent changes in antihypertensive treatment(s) in the last month, with the exception for diuretics where treatment stability of at least 3 months will be required
  • Patients who do not wish to participate to the study

结局指标

主要结局

Home blood pressure measurement

时间窗: before the initiation of bevacizumab and before each bevacizumab infusion, up to 10 weeks

Home blood pressure (systolic, diastolic) before each bevacizumab infusion, as the mean of 3 measures in the morning and 3 measures in the evening, over 3 days

次要结局

  • 24-hour proteinuria(before the initiation of bevacizumab and before each bevacizumab infusion, up to 10 weeks)
  • in-hospital blood pressure measurement(before the initiation of bevacizumab and before each bevacizumab infusion, up to 10 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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