Diurnal BP Patterns in Those at Increased Risk of CVD

Recruiting

• Conditions: Cardiovascular Risk Factor; Arterial Stiffness; Blood Pressure; Chronic Kidney Diseases
• Interventions: Diagnostic Test: Assessment of 24 hour blood pressure and arterial stiffness

• Registration Number: NCT04522765
• Lead Sponsor: University of Edinburgh

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-17
• Study First Submitted: 2020-08-14
• Study First Submitted QC: 2020-08-19
• Study First Posted: 2020-08-21
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-21
• Last Update Posted: 2024-05-22
• Primary Completion: 2024-08-01
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Acute kidney injury	Assessment of 24 hour blood pressure and arterial stiffness	Individuals with acute kidney injury as defined by KDIGO criteria
Chronic kidney disease	Assessment of 24 hour blood pressure and arterial stiffness	Individuals with chronic kidney disease as defined by KDIGO criteria
Small vessel vasculitis	Assessment of 24 hour blood pressure and arterial stiffness	Individuals with active small vessel vasculitis an diagnosed by a specialist physician
Health	Assessment of 24 hour blood pressure and arterial stiffness	Healthy individuals with no known medical condition and taking no regular medication
Kidney transplant recipient	Assessment of 24 hour blood pressure and arterial stiffness	Individuals who have received a kidney transplant
Kidney donor	Assessment of 24 hour blood pressure and arterial stiffness	Individuals who have donated a kidney for transplantation

Primary Outcome Measures

Name	Time	Method
Nocturnal arterial stiffness dip	24 hours	Percentage change between mean day-time and mean night-time arterial stiffness
Nocturnal BP dip	24 hours	Percentage change between mean day-time and mean night-time blood pressure

Secondary Outcome Measures

Name	Time	Method
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)
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)

Trial Locations

Locations (1)

Royal Infirmary of Edinburgh; 🇬🇧 Edinburgh, United Kingdom