Condition category
Circulatory System
Date applied
14/12/2010
Date assigned
16/12/2010
Last edited
05/08/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Neil Poulter

ORCID ID

Contact details

International Centre for Circulatory Health
59 North Wharf Road
London
W2 1PG
United Kingdom

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 measures

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

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

http://www3.imperial.ac.uk/

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

Results - basic reporting

Publication summary

2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27488944

Publication citations

Additional files

Editorial Notes

05/08/2016: Publication reference added.