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NCT Number: NCT01037530

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

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.

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Key information

Conditions

Intermittent Claudicants Cardiovascular Diseases Intermittent Claudication Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Vascular Diseases Signs and Symptoms Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hull and East Yorkshire Hospitals

Hull, Yorkshire, HU3 2JZ, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Ramipril

Drug

5 mg/day for 2 weeks then 10 mg/day for 22 weeks

Primary outcomes

  1. Maximum Walking Distance (MWD).

    Time frame: Baseline

    The primary outcome measure for this trial is the Maximum Walking Distance (MWD). Treadmill exercise test will be used to estimate the maximum distance the participant can walk at a speed of 2.5 km/h with a 10

Secondary outcomes

  1. Other Clinical Indicators of Lower Limb Ischaemia: a) Patient Reported Walking Distance (PRWD) b) Treadmill Intermittent Claudication Distance (ICD) c) Ankle Brachial Pressure Index at Rest (ABPI- r) and Following Treadmill Testing (ABPI - t)

    Time frame: Baseline

  2. Quality of Life: a) Generic - Measured Using the SF36, SF8 and EuroQol (EQ5D) Instruments b) Disease Specific - Measured Using the VascuQol

    Time frame: 0,2,6,24 weeks

  3. Cardiovascular Prognosis Using: a) Framingham, PROCAM, QRISK and Manchester Charts Scoring Systems b) B-type Natriuretic Peptide (BNP) and N- Terminal Prohormone BNP (NT-proBNP) and a Lipid Profile ( LDL, HDL, Total Cholesterol, Triglycerides)

    Time frame: 0,2,6,24 weeks

  4. Markers of Endothelial Function and Ischaemia Reperfusion a) IL6 b) Soluble Intercellular Adhesion Molecule-1 (sICAM -1) c) sE Selectin d) Urine Albumin Creatinine Ratio ( UACR)

    Time frame: 0,2,6,24 weeks

  5. Arterial Effects: a) Arterial Stiffness by Measuring the Pulse Wave Velocity and Assessing the Effects on the Extracellular Matrix by Measuring Metalloproteinases (MMPs) and Tissue Inhibitor Metalloproteinases (TIMPs). b) Flow Mediated Vasodilatation

    Time frame: 0,2,6,24 weeks

  6. Health Economics (Cost Effectiveness / Utility)

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

Hull University Teaching Hospitals NHS Trust

Other Gov

Collaborators

  • University of Hull

Registry information

Official study title

A Double Blind, Randomised, Placebo Controlled Trial to Study the Clinical and Cost Effectiveness of the Angiotensin Converting Enzyme Inhibitor, Ramipril, in Intermittent Claudicants

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Dec 23, 2009
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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