Ignite Creation Date:
2024-05-06 @ 5:37 PM
Last Modification Date:
2024-10-26 @ 2:32 PM
Study NCT ID:
NCT05376514
Status:
UNKNOWN
Last Update Posted:
2022-08-08
First Post:
2022-05-11
Brief Title:
Central Blood Pressure and Variability Evaluation
Sponsor:
Imperial College Healthcare NHS Trust
Organization:
Imperial College Healthcare NHS Trust
Study Overview
Official Title:
Investigation Into the Effects of Central Blood Pressure Variability and Antihypertensive Adherence on the Size and Growth Rate of Abdominal Aortic Aneurysms
Status:
UNKNOWN
Status Verified Date:
2022-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAVE-ON
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 55cm 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 55 cm or rupture
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 55cm 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 55 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 didnt 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 Marys 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 Marys and Northwick Park hospitals
Data Collection
1 Demographic data - eg 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 55 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 SDmean 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
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 Marys 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 Marys and Northwick Park hospitals
Data Collection
1 Demographic data - eg 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 55 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 SDmean 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None