Central Blood Pressure and Variability Evaluation

NCT05376514 | Completed

• 1 other identifier: 22SM7440
• Study Type: observational
• Target: 137
• Locations: 1 country
• Sites: 2

Brief Summary

Background: A sub-study of the AARDVARK (Aortic Aneurysmal Regression of Dilation: Value of ACE-Inhibition on RisK) trial indicated a statistically significant association between central blood pressure (BP) variability and abdominal aortic aneurysm (AAA) growth. The role of anti-hypertensive adherence has not been explored in the context of AAA growth. Objective: To confirm whether higher central BP variability is associated with higher AAA growth rates and to examine the effect of medication adherence on AAA growth rates in a prospective longitudinal cohort study. Methods: Up to 175 patients will be recruited over ten months from two sites with standardised quality control of AAA, BP and antihypertensive non-adherence measurement. Patients (\>55 years), with AAAs ≥3cm in diameter (including AAA ≥5.5cm, not proceeding to surgery) will be recruited and undergo AAA ultrasound (US), BP (peripheral and central) and antihypertensive non-adherence measurements every four months (+/- one month) for 24 months. Ambulatory BP variability data will be collected. Data on medication adherence and beliefs around medications will be collected with validated questionnaires. Analysis: Primarily, the relationship between central diastolic BP visit-to-visit variability and AAA growth (estimated by multilevel modelling) based on US measurements and secondarily the relationship between central diastolic BP variability and time taken to reach the threshold for AAA repair (5.5 cm) or rupture.

Conditions

AAA; Abdominal Aortic Aneurysm; Blood Pressure

Keywords

AAA; Central blood pressure; Growth; Medication adherence; Blood pressure variability

Outcome Measures

Primary Outcomes (1)

• Growth

  AAA growth as measured by multilevel modelling

  24 months

Secondary Outcomes (1)

• Time to rupture or repair

  24 months

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with an AAA currently under surveillance, or those with an AAA ≥5.5cm not proceeding to surgery.

You may qualify if:

• Willing and able to give written informed consent
• infrarenal aneurysms of ≥3cm in size (to include AAA ≥5.5cm in those not proceeding to surgery)

You may not qualify if:

• Patient's with a known genetic aetiology of their AAA
• age\<55
• known bilateral proximal upper extremity obstructive lesions
• persistent cardiac arrhythmia
• those unable to give informed consent
• those too frail to travel for four monthly surveillance
• any clinically significant medical condition which, in the opinion of the investigator, may interfere with the study results and/or reduce life expectancy to \< 2 years
• participation in another trial of an investigational product or device within the previous 30 days
• unable or unwilling to comply with the requirements of the study, in the opinion of the investigator

Sponsors & Collaborators

• Imperial College Healthcare NHS Trust: lead
• London North West Healthcare NHS Trust: collaborator

Study Sites (2)

Northwick Park Hospital, London North West Healthcare NHS Trust

London, HA1 3UJ, United Kingdom

Location

St Mary's Hospital, Imperial College Healthcare NHS Trust

London, W2 1NY, United Kingdom

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal; Medication Adherence

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2022
• First Posted: May 17, 2022
• Study Start: June 7, 2022
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: January 31, 2025

Record last verified: 2025-01

Locations

GB (2)