Central Blood Pressure and Variability Evaluation

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Abdominal aortic aneurysm
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Brief Title

Central Blood Pressure and Variability Evaluation

Official Title

Investigation Into the Effects of Central Blood Pressure Variability and Antihypertensive Adherence on the Size and Growth Rate of Abdominal Aortic Aneurysms

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.

Detailed Description

      The AARDVARK (Aortic Aneurysmal Regression of Dilation: Value of ACE-Inhibition on RisK)
      trial was designed to investigate the hypothesis that an ACE-inhibitor (perindopril) would
      reduce growth rate of small AAAs in a three-arm randomised placebo-controlled trial. While
      this didn't show a significant effect, results from an in-trial sub-study (CAVE study)
      demonstrated a significant relationship between central BP variability and aneurysm growth
      rates. This requires confirmation, in a dedicated study.

      Design:

      This is a multicentre prospective longitudinal observational cohort study. Each patient will
      have a study visit every 4 months with a minimum of 6 clinical visits where the study team
      will collect demographic data; psychological data (short form questionnaires that can be
      independently filled in); and physical data. The study team will also access routinely
      collected NHS cross-sectional imaging for comparison throughout the study, as quality
      control. No additional procedures involving ionising radiation will take place.

      Study timeline:

      There will be a 10-month recruitment period; all subjects will attend visits for a period of
      18-24 months. The data collection will continue for 24 months in total. There will be a
      6-month period of data analysis and write up.

      Recruitment:

      A cohort of up to 175 patients will be recruited from two trusts in London comprising four
      hospitals - Imperial College Healthcare NHS Trust (ICH) at St Mary's and Charing Cross
      hospitals, and London North West University Healthcare Trust (LNWH) at Northwick Park and
      Hillingdon hospitals. All visits and measurements will take place at central sites (St Mary's
      and Northwick Park hospitals).

      Data Collection:

        1. Demographic data - e.g. current prescribed anti-hypertensive medication and other
           cardiovascular medications, height and weight, medical history, smoking status

        2. Psychological data - three short-form questionnaires that can be independently filled in
           by participants. Questionnaires will constitute measures of anxiety and depression
           (Hospital Anxiety and Depression Score [HADS]), current medication adherence (modified
           Voils Adherence Score), and beliefs around medication and adherence (Beliefs about
           Medicines Questionnaire [BMQ]).

        3. Physical data - sitting mean peripheral and central systolic and diastolic BP,
           visit-to-visit central systolic and diastolic BP variability measured as standard
           deviation, coefficient of variation and variation independent of the mean will be
           measured using a validated arm cuff-based method. Ambulatory BP parameters will be
           measured using a validated monitor. USS AAA measurement will take place at bedside in
           supine position with outer-to-outer (OTO) calliper placement.

      Primary Endpoint Analysis:

      The association between central BP variability measured as standard deviation and AAA growth
      will be analysed using regression models where BP variability is the exposure and AAA growth
      is the outcome.

      Random effects multilevel models where level-1 units are AAA repeated measurements nested
      within patients (level-2 units) will be used to estimate AAA growth. To explore non-linearity
      in AAA growth appropriate modelling will be used eg. linear splines.

      Secondary Endpoints Analyses:

      Survival analysis techniques such as Cox proportional hazards models will be used to assess
      the relationship between central BP variability and time taken for the AAA to reach the
      threshold for intervention (5.5 cm) or rupture.

      Associations between haemodynamic parameters and aneurysm growth rate will be investigated.
      For each of the other measurements of systolic and diastolic central BP variability
      (coefficient of variation (SD ÷ mean) and variation independent of the mean calculated as
      SD÷(mean x) where x is determined empirically by curve fitting) and for other BP and
      haemodynamic parameters studied, the same multilevel model or generalised linear models will
      be used to estimate AAA growth. All analyses will be adjusted for an a-priori list of
      confounding variables.

Study Type

Observational [Patient Registry]

Primary Outcome

Growth

Secondary Outcome

 Time to rupture or repair

Condition

AAA

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Estimated Enrollment

175

Start Date

June 7, 2022

Completion Date

May 2024

Primary Completion Date

May 2024

Eligibility Criteria

        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

Gender

All

Ages

55 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, 02033126072, [email protected]

Location Countries

United Kingdom

Location Countries

United Kingdom

Administrative Informations

NCT ID

NCT05376514

Organization ID

22SM7440

Responsible Party

Sponsor

Study Sponsor

Imperial College Healthcare NHS Trust

Collaborators

 London North West Healthcare NHS Trust

Study Sponsor

, ,

Verification Date

August 2022