AARDVARK (Aortic Aneurysmal Regression of Dilation: Value of ACE-Inhibition on RisK)
Status:
Completed
Trial end date:
2015-04-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Imperial College London
Collaborator:
National Institute for Health Research, United Kingdom