Diurnal BP Patterns in Those at Increased Risk of CVD

Blood Pressure Clinical Trial

Official title:

Diurnal Blood Pressure and Arterial Stiffness Patterns in Those at Increased Risk of Cardiovascular Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04522765
• Other study ID #: AC19178
• Status: Recruiting
• Start date: March 17, 2020
• Est. completion date: March 31, 2025

Study information

• Verified date: May 2024
• Source: University of Edinburgh
• Contact: Neeraj Dhaun, MBChB PhD
• Phone: 07968810899
• Email: bean.dhaun[@]ed.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: March 31, 2025
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Arterial Stiffness
• Blood Pressure
• Cardiovascular Risk Factor
• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Diagnostic Test:
• Assessment of 24 hour blood pressure and arterial stiffness
Assessment of 24 hour blood pressure and arterial stiffness using Mobil-o-graph device

Locations

Country	Name	City	State
United Kingdom	Royal Infirmary of Edinburgh	Edinburgh

Sponsors (1)

Lead Sponsor	Collaborator
University of Edinburgh

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nocturnal BP dip	Percentage change between mean day-time and mean night-time blood pressure	24 hours
Primary	Nocturnal arterial stiffness dip	Percentage change between mean day-time and mean night-time arterial stiffness	24 hours
Secondary	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)	Morning (06:00-12:00) and evening (18:00-00:00)
Secondary	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)	Morning (06:00-12:00) and evening (18:00-00:00)