Diurnal BP Patterns in Those at Increased Risk of CVD

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorUniversity of Edinburgh

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Age <18 years and >90 years

Lack of ability to provide informed consent

Trial population

As above

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Assessment of 24 hour blood pressure and arterial stiffness

    Diagnostic test

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

Treatment groups

120 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Health1 intervention
Group B: Acute kidney injury1 intervention
Group C: Chronic kidney disease1 intervention
Group D: Small vessel vasculitis1 intervention
Group E: Kidney transplant recipient1 intervention
Group F: Kidney donor1 intervention

Trial outcomes

Primary outcomes

1

Nocturnal BP dip

Percentage change between mean day-time and mean night-time blood pressure

Time frame
24 hours
2

Nocturnal arterial stiffness dip

Percentage change between mean day-time and mean night-time arterial stiffness

Time frame
24 hours

Secondary outcomes

1

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)

Time frame
Morning (06:00-12:00) and evening (18:00-00:00)
2

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)

Time frame
Morning (06:00-12:00) and evening (18:00-00:00)

Other outcomes

Sponsors and contacts

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