AARDVARK (Aortic Aneurysmal Regression of Dilation: Value of ACE-Inhibition on RisK)
Condition: Abdominal Aortic Aneurysm
MeSH terms: Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
Intervention: perindopril arginine; amlodipine 5mgs; placebo
Intervention description: 10mgs orally daily for the duration of the trial; 5 mgs taken orally daily for the duration of the trial; one daily
Intervention MeSH terms: Amlodipine; Perindopril
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 224.0
Sex: All
Minimum age: 55 Years
Healthy volunteers: No
Keywords: abdominal aortic aneurysm; ACE Inhibition

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.
    

Eligibility criteria:

        Inclusion criteria:

        Willing and able to give written informed consent

        Men or women, aged at least 55 years

        With AAA 3 to 5.4 cm in diameter by internal or external measurement according to
        ultrasound

        A systolic BP <150mmHg (unless they require and are already receiving an ACE-inhibitor or
        amlodipine 10mg daily).

        Exclusion criteria:

        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/ora
        5mg dose of amlodipine for control (ie SBP < 150mmHg) of their BP.

        Those with known renal artery stenosis (>50%), or with a serum creatinine of >180µmol/L

        Those unable to give informed consent

        Those too frail to travel for 3-monthly surveillance will be excluded

        Any clinically significant medical condition which, in the opinion of the investigator, may
        interfere with the study results and or reduce life expectancy to < 2 years

        Participation in another trial of an investigational product or device within the previous
        30 days

        Known allergy or sensitivity to perindopril or amlodipine

        Unable or unwilling to comply with the requirements of the study, in the opinion of the
        investigator.