AARDVARK (Aortic Aneurysmal Regression of Dilation: Value of ACE-Inhibition on RisK)

Summary

Abdominal aortic aneurysms (AAA) are balloon-like swellings of the body's main blood vessel (aorta) as it courses through the abdomen. As a result of the National Aneurysm Screening programme many more of these will be detected. Small AAAs grow slowly and remain a benign condition until the diameter exceeds 2-3 times the diameter of the normal aorta (about 5.5cm in size), when operative repair of the aneurysm is recommended avoiding the potentially fatal event of bursting and bleeding (aneurysm rupture). It is therefore important to identify a strategy to prevent aneurysm growth.

There is a suggestion that the use of a specific drug class, angiotensin converting enzyme (ACE) inhibitors, may reduce the risk of rupture of the larger aneurysms. This trial will assess whether an ACE inhibitor (perindopril) has aneurysm-related benefits, in patients with small AAAs at screening centres in the London area.

The effects of perindopril versus a placebo(dummy) on AAA growth rates will be compared. In addition by comparing the effects of perindopril with the effects of equivalent blood pressure lowering with another non-ACE inhibitor class of drug (amlodipine) on aneurysm growth rate, we can see whether any benefits of perindopril are simply the result of lowering blood pressure. 225 Patients will be assigned to one of these 3 treatments by chance (randomisation).In addition to analysis of the effect of perindopril and blood pressure lowering,the effect of the treatments on quality of life will be assessed. Patients will return at 3-monthly intervals for an ultrasound scan and blood pressure measurements, with questionnaires regarding quality of life at the start and end of the 2-year research period.

An ultrasound scan is a painless test that uses sound waves to create images of organs and structures inside your body.

Conditions

• Abdominal Aortic Aneurysm

Interventions

DRUG

perindopril arginine

10mgs orally daily for the duration of the trial

DRUG

amlodipine 5mgs

5 mgs taken orally daily for the duration of the trial

DRUG

placebo

one daily

Sponsors & Collaborators

• National Institute for Health Research, United Kingdom

  collaborator OTHER_GOV

• Imperial College London

  lead OTHER

Principal Investigators

• Janet Powell, MD · Imperial College London

• Colin Bicknell, FRCS · Imperial College London

• Deborah Ashby, PhD · Imperial College London

• Meryl E Davis, FRCS · Royal Free Hospital NHS Trust

• Mathew Waltham, FRCS · Guys Hospital NHS trust

• Neil Poulter, FRCP · Imperial College London

• Christopher Imray, FRCS · University Hospitals Coventry & Warwickshire

• Dynesh Rittoo, FRCS · The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust

• Ian Chetter, FRCS · Hull University Teaching Hospitals NHS Trust

• Sohail Choksy, FRCS · East Suffolk and North Essex NHS Foundation Trust

• Tim Lees, FRCS · The Newcastle Hospitals NHS Foundation Trust

• Andrew Thompson, FRCS · York Teaching Hospital NHS Foundation Trust

• Vince Smyth, FRCS · Manchester University NHS Foundation Trust

• Shah Nawaz, FRCS · Sheffield Teaching Hospitals NHS Foundation Trust

• Andrew Brown, FRCS · City Hospitals Sunderland NHS Foundation Trust

• Felicity Meyer, FRCS · Norfolk and Norwich University Hospitals NHS Foundation Trust

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

55 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-09-30

Primary Completion

2015-04-30

Completion

2015-04-30

Countries

• United Kingdom

Study Locations