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Diurnal BP Patterns in Those at Increased Risk of CVD

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04522765
Enrollment
120
Registered
2020-08-21
Start date
2020-03-17
Completion date
2026-12-31
Last updated
2025-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arterial Stiffness, Blood Pressure, Cardiovascular Risk Factor, Chronic Kidney Diseases

Brief 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.

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

Sponsors

University of Edinburgh
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Nocturnal BP dip24 hoursPercentage change between mean day-time and mean night-time blood pressure
Nocturnal arterial stiffness dip24 hoursPercentage change between mean day-time and mean night-time arterial stiffness

Secondary

MeasureTime frameDescription
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)Measurement of urine ET-1 concentration in the morning (06:00 - 12:00) and in the 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)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)

Countries

United Kingdom

Contacts

Primary ContactNeeraj Dhaun, MBChB PhD
bean.dhaun@ed.ac.uk07968810899

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026