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临床试验/NCT04522765
NCT04522765招募中不适用

Diurnal Blood Pressure and Arterial Stiffness Patterns in Those at Increased Risk of Cardiovascular Disease

University of Edinburgh1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2020年3月17日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
120
试验地点
1
主要终点
Nocturnal arterial stiffness dip

研究概览

简要总结

In health, blood pressure (BP) falls at night by >10% compared with day-time values. This natural dipping pattern is important as without it there is an increased risk of cardiovascular disease (CVD). Recent evidence suggests that chronotherapy (taking anti-hypertensive medication at bedtime instead of in the morning) may enhance nocturnal BP dipping and reduce the risk of CVD events. There is therefore an urgent need to characterise diurnal BP patterns in patients who may be at risk of reduced nocturnal dipping in order to maximise protective therapy in all those who would benefit. Similarly, it has previously been demonstrated that increased arterial stiffness is associated with increased CVD risk, however little is known about whether loss of diurnal variations in arterial stiffness confer addition risk. Kidney disease is independently associated with increased CVD events, but the exact makeup of this risk is not clear. Within this heterogenous cohort several very distinct groups exist including those with acute kidney injury (AKI), chronic kidney disease (CKD), inflammatory conditions like small vessel vasculitis (SVV), and those who have either donated or received a kidney transplant. Diurnal BP and arterial stiffness patterns within these patient groups are not well characterised. The investigators will recruit patients at increased risk of CVD from the Royal Infirmary of Edinburgh Renal and Vasculitis Clinics. Participants will undergo 24-hour ambulatory BP and arterial stiffness measurement in conjunction with day- and night-time blood and urine sampling on two separate occasions. This study aims to characterise diurnal patterns of BP and arterial stiffness in patients at increased risk of CVD and compare findings with healthy controls. In doing so, the investigators aim to allow more targeted CVD risk reduction strategies and improve long-term patient outcomes.

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 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients will be eligible to take part in the study if they attend NHS Lothian inpatient or outpatient services and can be classified as being at increased risk of CVD. This will include, but is not limited to, the following subgroups:
  • CKD as defined by the Kidney Disease Outcome Quality Initiative (K/DOQI) classification
  • AKI as defined by the Kidney Disease Improving Global Outcomes (KDIGO) classification
  • Small vessel vasculitis
  • Kidney transplant recipient
  • Kidney donor We will also recruit a healthy control group from the community.

排除标准

  • Age <18 years and >90 years
  • Lack of ability to provide informed consent

结局指标

主要结局

Nocturnal arterial stiffness dip

时间窗: 24 hours

Percentage change between mean day-time and mean night-time arterial stiffness

Nocturnal BP dip

时间窗: 24 hours

Percentage change between mean day-time and mean night-time blood pressure

次要结局

  • Change in plasma ET-1 concentration when measured in the morning (06:00 - 12:00) and in the evening (18:00-00:00)(Morning (06:00-12:00) and evening (18:00-00:00))
  • Change in urine ET-1 concentration when measured in the morning (06:00 - 12:00) and in the evening (18:00-00:00)(Morning (06:00-12:00) and evening (18:00-00:00))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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