Investigation Into the Effects of Central Blood Pressure Variability and Antihypertensive Adherence on the Size and Growth Rate of Abdominal Aortic Aneurysms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 137
- 试验地点
- 2
- 主要终点
- Growth
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •Patient's with a known genetic aetiology of their AAA
- •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
结局指标
主要结局
Growth
时间窗: 24 months
AAA growth as measured by multilevel modelling
次要结局
- Time to rupture or repair(24 months)