Blood Pressure Clinical Trial
— CAVE-ONOfficial title:
Investigation Into the Effects of Central Blood Pressure Variability and Antihypertensive Adherence on the Size and Growth Rate of Abdominal Aortic Aneurysms
NCT number | NCT05376514 |
Other study ID # | 22SM7440 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 7, 2022 |
Est. completion date | May 2024 |
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.
Status | Recruiting |
Enrollment | 175 |
Est. completion date | May 2024 |
Est. primary completion date | May 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 55 Years and older |
Eligibility | Inclusion Criteria: - 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) Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Northwick Park Hospital, London North West Healthcare NHS Trust | London | |
United Kingdom | St Mary's Hospital, Imperial College Healthcare NHS Trust | London |
Lead Sponsor | Collaborator |
---|---|
Imperial College Healthcare NHS Trust | London North West Healthcare NHS Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Growth | AAA growth as measured by multilevel modelling | 24 months | |
Secondary | Time to rupture or repair | Time taken for patient's AAA to rupture or to reach threshold for repair | 24 months |
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