CompletedPhase 4

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

United Kingdom33 participantsStarted 2010-12

Plain-language 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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Maximum Walking Distance (MWD).

Timeframe: Baseline

Trial details

NCT IDNCT01037530

SponsorHull University Teaching Hospitals NHS Trust

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2012-12

Results submitted2022-04-19

View on ClinicalTrials.gov More Intermittent Claudicants trials