NCT04522765 Diurnal BP Patterns in Those at Increased Risk of CVD
| NCT ID | NCT04522765 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Edinburgh |
| Condition | Cardiovascular Risk Factor |
| Study Type | OBSERVATIONAL |
| Enrollment | 120 participants |
| Start Date | 2020-03-17 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 120 participants in total. It began in 2020-03-17 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Neeraj Dhaun, MBChB PhD
PRINCIPAL INVESTIGATOR
University of Edinburgh
Frequently Asked Questions
Who can join the NCT04522765 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Cardiovascular Risk Factor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04522765 currently recruiting?
Yes, NCT04522765 is actively recruiting participants. Contact the research team at bean.dhaun@ed.ac.uk for enrollment information.
Where is the NCT04522765 trial being conducted?
This trial is being conducted at Edinburgh, United Kingdom.
Who is sponsoring the NCT04522765 clinical trial?
NCT04522765 is sponsored by University of Edinburgh. The principal investigator is Neeraj Dhaun, MBChB PhD at University of Edinburgh. The trial plans to enroll 120 participants.