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心血管疾病风险增加人群的昼夜血压模式

2026年9月21日 更新者:University of Edinburgh

心血管疾病风险增加人群的昼夜血压和动脉硬度模式

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.

研究概览

研究类型

观察性的

注册 (估计的)

120

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

      • Edinburgh、英国、EH164SA
        • 招聘中
        • Royal Infirmary of Edinburgh
        • 接触:
          • Neeraj Dhaun, MBChB PhD

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 90年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

非概率样本

研究人群

As above

描述

Inclusion Criteria:

  • 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:

    1. CKD as defined by the Kidney Disease Outcome Quality Initiative (K/DOQI) classification
    2. AKI as defined by the Kidney Disease Improving Global Outcomes (KDIGO) classification
    3. Small vessel vasculitis
    4. Kidney transplant recipient
    5. Kidney donor We will also recruit a healthy control group from the community.

Exclusion Criteria:

  1. Age <18 years and >90 years
  2. Lack of ability to provide informed consent

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:COHORT
  • 时间观点:PROSPECTIVE

队列和干预

团体/队列
干预/治疗
Health

Healthy individuals with no known medical condition and taking no regular medication

Assessment of 24 hour blood pressure and arterial stiffness using Mobil-o-graph device

Acute kidney injury

Individuals with acute kidney injury as defined by KDIGO criteria

Assessment of 24 hour blood pressure and arterial stiffness using Mobil-o-graph device

Chronic kidney disease

Individuals with chronic kidney disease as defined by KDIGO criteria

Assessment of 24 hour blood pressure and arterial stiffness using Mobil-o-graph device

Small vessel vasculitis

Individuals with active small vessel vasculitis an diagnosed by a specialist physician

Assessment of 24 hour blood pressure and arterial stiffness using Mobil-o-graph device

Kidney transplant recipient

Individuals who have received a kidney transplant

Assessment of 24 hour blood pressure and arterial stiffness using Mobil-o-graph device

Kidney donor

Individuals who have donated a kidney for transplantation

Assessment of 24 hour blood pressure and arterial stiffness using Mobil-o-graph device

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Nocturnal BP dip
大体时间:24 hours

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

24 hours
Nocturnal arterial stiffness dip
大体时间:24 hours

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

24 hours

次要结果测量

结果测量
措施说明
大体时间
Change in urine ET-1 concentration when measured in the morning (06:00 - 12:00) and in the evening (18:00-00:00)
大体时间:Morning (06:00-12:00) and evening (18:00-00:00)

Measurement of urine ET-1 concentration 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 plasma ET-1 concentration when measured in the morning (06:00 - 12:00) and in the evening (18:00-00:00)
大体时间:Morning (06:00-12:00) and evening (18:00-00:00)

Measurement of plasma ET-1 concentration 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)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Neeraj Dhaun, MBChB PhD、University of Edinburgh

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2020年3月17日

初级完成 (估计的)

2026年12月31日

研究完成 (估计的)

2026年12月31日

研究注册日期

首次提交

2020年8月14日

首先提交符合 QC 标准的

2020年8月19日

首次发布 (实际的)

2020年8月21日

研究记录更新

最后更新发布 (实际的)

2026年9月24日

上次提交的符合 QC 标准的更新

2026年9月21日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

There is no plan to share IPD

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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