Cardiovascular Risk FactorNCT04522765
Diurnal BP Patterns in Those at Increased Risk of CVD
An observational study of Cardiovascular Risk Factor and Blood Pressure, run by University of Edinburgh at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk Factor, Blood Pressure, Arterial Stiffness
- What is being tested?
- Assessment of 24 hour blood pressure and arterial stiffness
- How many people
- 120 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Mar 2020to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: As above
Who may be able to join
- 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.
Who cannot join
- Age <18 years and >90 years
- Lack of ability to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Infirmary of Edinburgh
Edinburgh, EH164SA
Neeraj Dhaun, MBChB PhD
About this study
Official title: Diurnal Blood Pressure and Arterial Stiffness Patterns in Those at Increased Risk of Cardiovascular Disease
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.
- Being tested
- Assessment of 24 hour blood pressure and arterial stiffness
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of 24 hour blood pressure and arterial stiffnessDiagnostic test
Assessment of 24 hour blood pressure and arterial stiffness using Mobil-o-graph device
| Study group | Role | What they receive |
|---|---|---|
| Health | Healthy individuals with no known medical condition and taking no regular medication Receives: Diagnostic Test: Assessment of 24 hour blood pressure and arterial stiffness | |
| Acute kidney injury | Individuals with acute kidney injury as defined by KDIGO criteria Receives: Diagnostic Test: Assessment of 24 hour blood pressure and arterial stiffness | |
| Chronic kidney disease | Individuals with chronic kidney disease as defined by KDIGO criteria Receives: 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 Receives: Diagnostic Test: Assessment of 24 hour blood pressure and arterial stiffness | |
| Kidney transplant recipient | Individuals who have received a kidney transplant Receives: Diagnostic Test: Assessment of 24 hour blood pressure and arterial stiffness | |
| Kidney donor | Individuals who have donated a kidney for transplantation Receives: Diagnostic Test: Assessment of 24 hour blood pressure and arterial stiffness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nocturnal BP dip
Percentage change between mean day-time and mean night-time blood pressure
Measured: 24 hours
Nocturnal arterial stiffness dip
Percentage change between mean day-time and mean night-time arterial stiffness
Measured: 24 hours
Secondary outcomes (2)
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)
Measured: 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)
Measurement of plasma ET-1 concentration in the morning (06:00 - 12:00) and in the evening (18:00-00:00)
Measured: Morning (06:00-12:00) and evening (18:00-00:00)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2020
- Study start17 Mar 2020
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Risk FactorStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neeraj Dhaun, MBChB PhD, Principal investigator, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04522765
- Sponsor's protocol ID
- AC19178
- Status last verified
- Sep 2026
- First submitted
- 14 Aug 2020
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diurnal Blood Pressure and Arterial Stiffness Patterns in Those at Increased Risk of Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT04522765
- Acronym / sponsor ID
- AC19178
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Study start
- 17 Mar 2020 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 21 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Health | – | Diagnostic Test: Assessment of 24 hour blood pressure and arterial stiffnessHealthy individuals with no known medical condition and taking no regular medication |
| Acute kidney injury | – | Diagnostic Test: Assessment of 24 hour blood pressure and arterial stiffnessIndividuals with acute kidney injury as defined by KDIGO criteria |
| Chronic kidney disease | – | Diagnostic Test: Assessment of 24 hour blood pressure and arterial stiffnessIndividuals with chronic kidney disease as defined by KDIGO criteria |
| Small vessel vasculitis | – | Diagnostic Test: Assessment of 24 hour blood pressure and arterial stiffnessIndividuals with active small vessel vasculitis an diagnosed by a specialist physician |
| Kidney transplant recipient | – | Diagnostic Test: Assessment of 24 hour blood pressure and arterial stiffnessIndividuals who have received a kidney transplant |
| Kidney donor | – | Diagnostic Test: Assessment of 24 hour blood pressure and arterial stiffnessIndividuals who have donated a kidney for transplantation |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- As above
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (2 listed)
- Age <18 years and >90 years
- Lack of ability to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment of 24 hour blood pressure and arterial stiffnessAssessment of 24 hour blood pressure and arterial stiffness using Mobil-o-graph device | Diagnostic test | Acute kidney injury, Chronic kidney disease, Health, Kidney donor, Kidney transplant recipient, Small vessel vasculitis |
Primary outcome
Nocturnal BP dip
Time frame: 24 hours
Percentage change between mean day-time and mean night-time blood pressure
Nocturnal arterial stiffness dip
Time frame: 24 hours
Percentage change between mean day-time and mean night-time arterial stiffness
2 secondary outcomes
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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: No. There is no plan to share IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Neeraj Dhaun, MBChB PhD principal investigator
University of Edinburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Risk Factor and Blood Pressure, run by University of Edinburgh at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Neeraj Dhaun, MBChB PhD (07968810899, bean.dhaun@ed.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nocturnal BP dip (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.