Diurnal BP Patterns in Those at Increased Risk of CVD

University of Edinburgh

Status: Enrolling

Conditions: Chronic Kidney Diseases; Cardiovascular Risk Factor; Blood Pressure; Arterial Stiffness

Treatments: Diagnostic Test: Assessment of 24 hour blood pressure and arterial stiffness

Study type: Observational

Funder types: Other

Identifiers

NCT04522765

AC19178

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

120 participants in 6 patient groups

Health

Description:

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

Treatment:

Diagnostic Test: Assessment of 24 hour blood pressure and arterial stiffness

Acute kidney injury

Description:

Individuals with acute kidney injury as defined by KDIGO criteria

Treatment:

Diagnostic Test: Assessment of 24 hour blood pressure and arterial stiffness

Chronic kidney disease

Description:

Individuals with chronic kidney disease as defined by KDIGO criteria

Treatment:

Diagnostic Test: Assessment of 24 hour blood pressure and arterial stiffness

Small vessel vasculitis

Description:

Individuals with active small vessel vasculitis an diagnosed by a specialist physician

Treatment:

Diagnostic Test: Assessment of 24 hour blood pressure and arterial stiffness

Kidney transplant recipient

Description:

Individuals who have received a kidney transplant

Treatment:

Diagnostic Test: Assessment of 24 hour blood pressure and arterial stiffness

Kidney donor

Description:

Individuals who have donated a kidney for transplantation

Treatment:

Diagnostic Test: Assessment of 24 hour blood pressure and arterial stiffness