Diurnal BP Patterns in Those at Increased Risk of CVD

NCT ID: NCT04522765

Last Updated: 2025-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-17

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cardiovascular Risk Factor Blood Pressure Arterial Stiffness Chronic Kidney Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Health

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

Assessment of 24 hour blood pressure and arterial stiffness

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Assessment of 24 hour blood pressure and arterial stiffness

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Edinburgh

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Neeraj Dhaun, MBChB PhD

Role: PRINCIPAL_INVESTIGATOR

University of Edinburgh

Locations

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Royal Infirmary of Edinburgh

Edinburgh, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Neeraj Dhaun, MBChB PhD

Role: CONTACT

07968810899

Facility Contacts

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Neeraj Dhaun, MBChB PhD

Role: primary

Other Identifiers

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AC19178

Identifier Type: -

Identifier Source: org_study_id

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