Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT01118520
Protocol/serial number
HTA 08/109/02; CRO 1644/ 01
Study information
Scientific title
An evaluation of the effect of an angiotensin-converting enzyme (ACE) inhibitor on the growth rate of small abdominal aortic aneurysms
Acronym
AARDVARK (Aortic Aneurysmal Regression of Dilation: Value of Ace-inhibition on RisK)
Study hypothesis
To investigate the hypothesis that an angiotensin-converting enzyme (ACE)-inhibitor reduces abdominal aortic aneurysm (AAA) growth rate in a three-arm randomised controlled pilot trial. The three interventions are ACE-inhibition with perindopril versus equivalent blood pressure reduction with amlodipine (a calcium channel blocker) versus placebo. By comparing the effects in the perindopril and amlodipine arms, this design will permit an evaluation of any BP independent effects of perindopril.
More details can be found at: http://www.nets.nihr.ac.uk/projects/hta/0810902
Protocol can be found at: http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0003/51987/PRO-08-109-02.pdf
Ethics approval
West London Research Ethics Committee 2, 29/11/2010, ref: 10/H0711/80
Study design
Single-blind multicentre placebo-controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Asymptomatic abdominal aortic aneurysm
Intervention
This study will be performed at five investigational sites in the UK. This is a randomised, single-blind, multicentre, placebo-controlled study in participants with an systolic blood pressure (SBP) less than 150 mmHg either untreated or on treatment with certain pre-specified background anti-hypertensive medications. The pilot trial will have 3 arms, with patients being randomised to either perindopril (10 mg arginine salt daily) or placebo (primary comparison) or amlodipine (5 mg daily) (secondary comparison). The perindopril and amlodipine doses will have similar effects on blood pressure reduction and hence the secondary comparison will help to inform whether all/any benefits of perindopril are independent of BP reduction. If during the trial an individual patient's aneurysm should reach 5.5 cm in diameter, this patient will be referred back to the vascular surgeons in the normal surveillance programme. This assessment should take place within 2 weeks.
Follow up is 2 years.
Intervention type
Drug
Phase
Phase IV
Drug names
Perindopril, amlodipine
Primary outcome measure
Aneurysm growth rate, estimated using multilevel modelling. Patients will have their maximum anterior-posterior aneurysm diameter measured by ultrasonography at 3-monthly intervals, using a dedicated trial co-ordinator.
Secondary outcome measures
The three interventions are ACE-inhibition with perindopril versus equivalent BP reduction with amlodipine (a calcium channel blocker) versus placebo. By comparing the effects in the perindopril and amlodipine arms, this design will permit an evaluation of any BP independent effects of perindopril.
Modelling of time taken for the aneurysm to reach the threshold for intervention (5.5 cm) and formal comparison of the reproducibility of internal and external aneurysm diameters. Quality of life (Euroquol 5D) and health resource questionnaires will be administered after 12 and 24 months of follow up.
Overall trial start date
01/03/2011
Overall trial end date
01/03/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Willing and able to give written informed consent
2. Men or women, aged at least 60 years
3. AAA 3 to 5.4 cm in diameter according to ultrasound measurement
4. Systolic blood pressure (SBP) less than 150 mmHg (unless they require and are already receiving an ACE-inhibitor or amlodipine 10 mg daily). For patients whose SBP is greater than 150 mmHg, a 6-week course of the diuretic indapamide SR (1.5 mg daily) will be given, with re-evaluation of BP in the 6th week. If the SBP falls to less than 150 mmHg on this medication subjects would then be eligible for randomisation into the study. If this diuretic treatment is not appropriate then 5 mg of amlodipine could be prescribed by the patients GP if not already taking this drug. This would be followed by a six week re-evaluation as above.
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
225 participants
Participant exclusion criteria
1. Patients who are already required to take either an ACE-inhibitor or a calcium channel blocker or Angiotensin II blocker (ARB) who cannot be converted to diuretic therapy and/or a 5 mg dose of amlodipine for control (i.e., SBP less than 150 mmHg) of their BP
2. Those with known renal artery stenosis (greater than 50%), or with a serum creatinine of greater than 180 µmol/L
3. Those unable to give informed consent
4. Those too frail to travel for 3-monthly surveillance
5. Any clinically significant medical condition which, in the opinion of the investigator, may interfere with the study results and or reduce life expectancy to less than 2 years
6. Participation in another trial of an investigational product or device within the previous 30 days
7. Known allergy or sensitivity to perindopril or amlodipine
8. Unable or unwilling to comply with the requirements of the study, in the opinion of the investigator
Recruitment start date
01/03/2011
Recruitment end date
01/04/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
International Centre for Circulatory Health
London
W2 1PG
United Kingdom
Sponsor information
Organisation
Imperial College London (UK)
Sponsor details
Faculty of Medicine
G02 Sir Alexander Fleming Building
South Kensington Campus
London
SW7 2AZ
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Health Technology Assessment Programme
Alternative name(s)
NIHR Health Technology Assessment Programme, HTA
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
01/06/2016
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27488944