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

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 Overview

• Status: Recruiting
• Conditions: Chronic Kidney Diseases; Blood Pressure; Cardiovascular Risk Factor; Arterial Stiffness
• Intervention / Treatment: Diagnostic test: Assessment of 24 hour blood pressure and arterial stiffness

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Neeraj Dhaun, MBChB PhD; Phone Number: 07968810899; Email: bean.dhaun@ed.ac.uk

Study Locations

• United Kingdom
  • Edinburgh, United Kingdom, EH164SA
    • Recruiting
    • Royal Infirmary of Edinburgh
    • Contact: Neeraj Dhaun, MBChB PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

As above

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: COHORT
• Time Perspectives: PROSPECTIVE

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Health; Healthy individuals with no known medical condition and taking no regular medication	Diagnostic test: Assessment of 24 hour blood pressure and arterial stiffness; 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	Diagnostic test: Assessment of 24 hour blood pressure and arterial stiffness; 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	Diagnostic test: Assessment of 24 hour blood pressure and arterial stiffness; 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	Diagnostic test: Assessment of 24 hour blood pressure and arterial stiffness; Assessment of 24 hour blood pressure and arterial stiffness using Mobil-o-graph device
Kidney transplant recipient; Individuals who have received a kidney transplant	Diagnostic test: Assessment of 24 hour blood pressure and arterial stiffness; Assessment of 24 hour blood pressure and arterial stiffness using Mobil-o-graph device
Kidney donor; Individuals who have donated a kidney for transplantation	Diagnostic test: Assessment of 24 hour blood pressure and arterial stiffness; Assessment of 24 hour blood pressure and arterial stiffness using Mobil-o-graph device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nocturnal BP dip	Percentage change between mean day-time and mean night-time blood pressure	24 hours
Nocturnal arterial stiffness dip	Percentage change between mean day-time and mean night-time arterial stiffness	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	Morning (06:00-12:00) and evening (18:00-00:00)

Collaborators and Investigators

• Sponsor: University of Edinburgh
• Investigators: Principal Investigator: Neeraj Dhaun, MBChB PhD, University of Edinburgh

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2020
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: August 14, 2020
• First Submitted That Met QC Criteria: August 19, 2020
• First Posted (Actual): August 21, 2020

Study Record Updates

• Last Update Posted (Actual): September 24, 2026
• Last Update Submitted That Met QC Criteria: September 21, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic; Diagnostic Techniques and Procedures; Diagnosis; Circulatory and Respiratory Physiological Phenomena; Physical Examination; Vital Signs; Hemodynamics; Cardiovascular Physiological Phenomena; Blood Pressure; Vascular Stiffness
• Other Study ID Numbers: AC19178

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

There is no plan to share IPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No