Ignite Creation Date:
2024-05-05 @ 10:27 PM
Last Modification Date:
2024-10-26 @ 10:19 AM
Study NCT ID:
NCT01118520
Status:
COMPLETED
Last Update Posted:
2021-01-26
First Post:
2010-05-05
Brief Title:
AARDVARK Aortic Aneurysmal Regression of Dilation Value of ACE-Inhibition on RisK
Sponsor:
Imperial College London
Organization:
Imperial College London
Study Overview
Official Title:
An Evaluation of the Effect of an Angiotensin-converting Enzyme ACE Inhibitor on the Growth Rate of Small Abdominal Aortic Aneurysms
Status:
COMPLETED
Status Verified Date:
2021-01
Last Known Status:
None
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:
AARDVARK
Brief Summary:
Abdominal aortic aneurysms AAA are balloon-like swellings of the bodys 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 55cm 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 placebodummy 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 randomisationIn addition to analysis of the effect of perindopril and blood pressure loweringthe 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
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 placebodummy 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 randomisationIn addition to analysis of the effect of perindopril and blood pressure loweringthe 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
Detailed Description:
This trial will investigate the idea that an ACE-inhibitor reduces abdominal aortic aneurysm AAA growth rate in a pilot 3-arm randomised controlled trial ie the study treatment is chosen by random for each patient The three interventions are ACE-inhibition with perindopril equivalent blood pressure reduction with amlodipine a calcium channel blocker and a placebo tablet By comparing the effects in the perindopril and amlodipine arms this design will permit an evaluation of any blood pressure independent effects of perindopril
Pending results of this pilot trial we plan to work with the local and National Aneurysm Screening programme to conduct a larger definitive trial to investigate the hypothesis that blood pressure reduction with an ACE-inhibitor slows the rate of small AAA growth preferentially compared with other antihypertensive agents
Secondary research questions in this trial are the effects of perindopril therapy on aneurysm-related death rates other diseases possibly caused by an AAA and quality of life compared to similar blood pressure lowering effects with amlodipine and placebo
Pending results of this pilot trial we plan to work with the local and National Aneurysm Screening programme to conduct a larger definitive trial to investigate the hypothesis that blood pressure reduction with an ACE-inhibitor slows the rate of small AAA growth preferentially compared with other antihypertensive agents
Secondary research questions in this trial are the effects of perindopril therapy on aneurysm-related death rates other diseases possibly caused by an AAA and quality of life compared to similar blood pressure lowering effects with amlodipine and placebo
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 0810902 | OTHER_GRANT | NIHR | None |
| 2010-020226-17 | EUDRACT_NUMBER | None | None |