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临床试验/NCT04014127
NCT04014127Unknown不适用

Coronary Microvascular Dysfunction in Chronic Kidney Disease: The Chronic Renal Impairment in Birmingham Coronary Flow Reserve (CRIB FLOW) Study

University Hospital Birmingham NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年5月7日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
1
主要终点
Coronary flow reserve

研究概览

简要总结

This is an observational study assessing coronary microvascular function in healthy controls with normal kidney function, living kidney donors, pre-dialysis patients with chronic kidney disease stage 5 and patients on peritoneal dialysis.

详细描述

The clinical syndrome of uraemic cardiomyopathy is prevalent in end stage renal disease and is associated with pathological cardiovascular changes including left ventricular hypertrophy, diastolic dysfunction and diffuse interstitial fibrosis. These combine to confer an elevated cardiovascular risk, including an increased risk of sudden cardiac death.

The cause of this increased cardiovascular risk is not clear but it is thought that coronary microvascular dysfunction may play a role. Coronary microvascular dysfunction is prevalent in many myocardial disease states, such as hypertrophic cardiomyopathy and heart failure with preserved ejection fraction, that share pathological similarities with uraemic cardiomyopathy.

Coronary flow reserve, a marker of coronary microvascular function, can be assessed non-invasively using echocardiography techniques. Previous studies have shown a reduction in coronary flow reserve in patients with chronic kidney disease. However, it is not clear if kidney donors - individuals who have a reduced kidney function but do not have progressive kidney disease - also demonstrate microvascular dysfunction. Similarly, although there is some evidence that patients on dialysis have improved coronary flow reserve compared to patients with pre-dialysis chronic kidney disease stage 5, there has been limited investigation into the role of peritoneal dialysis on coronary flow reserve.

研究设计

研究类型
Observational
观察模型
Other
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

  • Healthy control with normal renal function
  • Living kidney donor who has donated >12 months prior to enrolment in study
  • Chronic kidney disease stage 5 who are pre-dialysis or on peritoneal dialysis
  • Able to provide written informed consent

排除标准

  • Pregnancy
  • Known ischaemic heart disease
  • Diabetes mellitus
  • Uncontrolled hypertension
  • Evidence of 2nd or 3rd degree AV block or sick sinus syndrome in absence of a pacemaker
  • History of allergic/adverse reaction to adenosine or Sonovue
  • History of long QT syndrome
  • Severe hypotension
  • Significant valvular heart disease
  • Significant chronic obstructive pulmonary disease or asthma with bronchospasm
  • Unstable angina not controlled with medication
  • Concurrent use of dipyridamole
  • Decompensated heart failure
  • Poor echo acoustic windows
  • Chronic kidney disease stage 5 on haemodialysis

结局指标

主要结局

Coronary flow reserve

时间窗: One baseline visit

Ultrasound-assessed coronary flow reserve. Data will be presented as a ratio (no unit) between maximal mean hyperemia flow velocity and baseline velocity

次要结局

  • Myocardial blood flow(One baseline visit)
  • Left ventricular ejection fraction(One baseline visit)

研究者

发起方
University Hospital Birmingham NHS Foundation Trust
申办方类型
Other
责任方
Principal Investigator
主要研究者

Anna Price

Co-Investigator

University Hospital Birmingham NHS Foundation Trust

研究点 (1)

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