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RecruitingNCT04522765Updated Sep 24, 2026

Diurnal BP Patterns in Those at Increased Risk of CVD

An observational study in Cardiovascular Risk Factor, Blood Pressure and Arterial Stiffness, sponsored by University of Edinburgh. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-24.

Sponsored by University of Edinburgh · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
120
Ages
18 Years to 90 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Cardiovascular Risk Factor
  • Blood Pressure
  • Arterial Stiffness
  • Chronic Kidney Diseases
03

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

As above

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

Exclusion Criteria:

  1. Age \<18 years and >90 years
  2. Lack of ability to provide informed consent
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
120 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Health

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

    Diagnostic Test: Assessment of 24 hour blood pressure and arterial stiffness

  • Acute kidney injury

    Individuals with acute kidney injury as defined by KDIGO criteria

    Diagnostic Test: Assessment of 24 hour blood pressure and arterial stiffness

  • Chronic kidney disease

    Individuals with chronic kidney disease as defined by KDIGO criteria

    Diagnostic Test: Assessment of 24 hour blood pressure and arterial stiffness

  • Small vessel vasculitis

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

    Diagnostic Test: Assessment of 24 hour blood pressure and arterial stiffness

  • Kidney transplant recipient

    Individuals who have received a kidney transplant

    Diagnostic Test: Assessment of 24 hour blood pressure and arterial stiffness

  • Kidney donor

    Individuals who have donated a kidney for transplantation

    Diagnostic Test: Assessment of 24 hour blood pressure and arterial stiffness

Interventions

  • Diagnostic testAssessment of 24 hour blood pressure and arterial stiffness

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

05

What researchers measure

Primary outcomes

  1. Nocturnal BP dip

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

    Time frame: 24 hours

  2. Nocturnal arterial stiffness dip

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

    Time frame: 24 hours

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)

    Measurement of urine ET-1 concentration 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)

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

    Time frame: Morning (06:00-12:00) and evening (18:00-00:00)

06

Study locations

1 of 1 sites recruiting
  • Royal Infirmary of Edinburgh
    Edinburgh, EH164SA, United Kingdom
    • Neeraj Dhaun, MBChB PhD · Contact
    Recruiting
07

References and documents

Individual participant data

Plan to share: No — There is no plan to share IPD

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04522765
Lead sponsor
University of Edinburgh
Responsible party
Sponsor
First posted
Aug 21, 2020
Start date
Mar 17, 2020
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Sep 24, 2026

Study contacts

Neeraj Dhaun, MBChB PhD
Contact
bean.dhaun@ed.ac.uk
07968810899
Neeraj Dhaun, MBChB PhD
principal investigator · University of Edinburgh

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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