Clinical and Cost Effectiveness of ACE Inhibitor, Ramipril, in Intermittent Claudicants

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The investigators are conducting a randomised controlled trial to investigate the clinical and cost effectiveness of Ramipril which is an anti-hypertensive medication in patients with intermittent claudication. The investigators aim to recruit 78 participants in total. The investigators will randomise the 78 participants into two groups: Ramipril group with 39 participants and Placebo group with 39 participants. The investigators will measure Ramipril's effect on walking by doing a simple treadmill test and measuring the maximum walking distance the participant can walk. The investigators also want to examine Ramipril's effect on arterial function, cardiovascular prognosis, quality of life and cost effectiveness.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daniel Carradice
• Treatments: Angiotensin-Converting Enzyme Inhibitors; Ramipril

Criteria

Inclusion Criteria:

• Patients with unilateral or bilateral intermittent leg claudication which was stable for the last 6 months.

• Patients with ABPI < 0.9 at rest at least in one leg.

• BP ≤ 160/90 and a stable medication regimen for the last 6 months.

• Able to give informed consent

• Able to comply with study protocol

Exclusion Criteria:

• Documented bilateral renal artery stenosis

• Unlikely to be compliant with medication or follow up as determined by the recruiting institution.

• Pregnancy

• Patients with critical limb ischemia (This includes patients with ischaemic rest pain and ulceration > 2 weeks and/or a resting ankle pressure < 50mmHg- Grades II and III according to Rutherford et al 1997.[56].

• Patients who had a recent (less than 3 months) angioplasty or bypass surgery

• Patients who are unable to perform a treadmill test due to a limiting heart, respiratory or arthritic disease

• History of angioneurotic oedema

• Currently taking ACE inhibitor or Angiotensin receptor blocker

• Contraindication to ACE inhibitor

• History of ACE inhibitor intolerance

• A creatinine rise of > 30% from baseline and/or Potassium > 5.9 mmol/l

• Unwillingness to participate.

• Level 1 evidence for ACE inhibitor treatment, including:

• Documented heart failure, left ventricular dysfunction or ejection fraction <35% on previous echocardiography

• Uncontrolled hypertension, BP > 160mmHg systolic or 100mmHg diastolic on 3 separate readings measured after 10 minutes rest on 2 separate occasions

• Recent (< 3months) myocardial infarction or stroke

• Chronic renal impairment (serum creatinine > 250 micromol/l)