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

Daniel Carradice

Status and phase

Completed

Phase 4

Conditions

Intermittent Claudicants

Treatments

Drug: Ramipril

Study type

Interventional

Funder types

Other

Identifiers

NCT01037530

2009-016600-23 (Registry Identifier)

05102009

Details and patient eligibility

About

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.

Enrollment

33 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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)