An evaluation of the effect of an angiotensin-converting enzyme (ACE) inhibitor on the growth rate of small abdominal aortic aneurysms
| ISRCTN | ISRCTN51383267 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN51383267 |
| ClinicalTrials.gov number | NCT01118520 |
| Secondary identifying numbers | HTA 08/109/02; CRO 1644/ 01 |
- Submission date
- 14/12/2010
- Registration date
- 16/12/2010
- Last edited
- 05/08/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Neil Poulter
Scientific
Scientific
International Centre for Circulatory Health
59 North Wharf Road
London
W2 1PG
United Kingdom
Study information
| Study design | Single-blind multicentre placebo-controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | An evaluation of the effect of an angiotensin-converting enzyme (ACE) inhibitor on the growth rate of small abdominal aortic aneurysms |
| Study acronym | AARDVARK (Aortic Aneurysmal Regression of Dilation: Value of Ace-inhibition on RisK) |
| Study objectives | 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(s) | West London Research Ethics Committee 2, 29/11/2010, ref: 10/H0711/80 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/03/2011 |
| Completion date | 01/03/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 225 participants |
| Key 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. |
| Key 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 |
| Date of first enrolment | 01/03/2011 |
| Date of final enrolment | 01/04/2013 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
International Centre for Circulatory Health
London
W2 1PG
United Kingdom
W2 1PG
United Kingdom
Sponsor information
Imperial College London (UK)
University/education
University/education
Faculty of Medicine
G02 Sir Alexander Fleming Building
South Kensington Campus
London
SW7 2AZ
England
United Kingdom
| Website | http://www3.imperial.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/041kmwe10 |
Funders
Funder type
Government
Health Technology Assessment Programme
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/06/2016 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2016 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
05/08/2016: Publication reference added.
