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NCT Number: NCT04522765

Diurnal BP Patterns in Those at Increased Risk of CVD

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal Infirmary of Edinburgh

Edinburgh, EH164SA, United Kingdom

Location status: Recruiting

Location contact

Neeraj Dhaun, MBChB PhD

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:
  • 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.

Exclusion criteria

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

Treatment and study plan

Assessment of 24 hour blood pressure and arterial stiffness

Diagnostic Test

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

Primary outcomes

  1. Nocturnal BP dip

    Time frame: 24 hours

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

  2. Nocturnal arterial stiffness dip

    Time frame: 24 hours

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

Secondary outcomes

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

    Time frame: 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)

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

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Neeraj Dhaun, MBChB PhD

CONTACT

[email protected]

07968810899

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Aug 21, 2020
Registry last updated
Sep 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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