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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

120

participants targeted

Target at P50-P75 for all trials

Timeline

8mo left

Started Mar 2020

Longer than P75 for all trials

Geographic Reach

1 country

1 active site

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

6.8 years study duration

Study Progress90%

Mar 2020Dec 2026

Study Start

First participant enrolled

March 17, 2020

Completed

5 months until next milestone

First Submitted

Initial submission to the registry

August 14, 2020

Completed

7 days until next milestone

First Posted

Study publicly available on registry

August 21, 2020

Completed

6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

September 23, 2025

Status Verified

September 1, 2025

Enrollment Period

6.8 years

First QC Date

August 14, 2020

Last Update Submit

September 18, 2025

Conditions

Cardiovascular Risk Factor Blood Pressure Arterial Stiffness Chronic Kidney Diseases

Outcome Measures

Primary Outcomes (2)

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 Outcomes (2)

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)
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)