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

NCT01037530 | Completed Phase 4 Results DMC

• 2 other identifiers: 051020092009-016600-23
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intermittent Claudicants

Keywords

ACE inhibitors; Intermittent claudication; Ramipril

Outcome Measures

Primary Outcomes (1)

• Maximum Walking Distance (MWD).

  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

  Baseline

Secondary Outcomes (6)

• 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)

  Baseline

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

  0,2,6,24 weeks

• 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)

  0,2,6,24 weeks

• 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)

  0,2,6,24 weeks

• 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

  0,2,6,24 weeks

Study Arms (2)

Ramipril

EXPERIMENTAL

Drug: Ramipril

Placebo

PLACEBO COMPARATOR

Drug: Ramipril

Interventions

Ramipril DRUG

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

Placebo; Ramipril

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hull University Teaching Hospitals NHS Trust: lead
• University of Hull: collaborator

Study Sites (1)

Hull and East Yorkshire Hospitals

Hull, Yorkshire, HU3 2JZ, United Kingdom

Location

Related Publications (1)

• Shahin Y, Cockcroft JR, Chetter IC. Randomized clinical trial of angiotensin-converting enzyme inhibitor, ramipril, in patients with intermittent claudication. Br J Surg. 2013 Aug;100(9):1154-63. doi: 10.1002/bjs.9198.

  PMID: 23842829 RESULT

Related Links

• Related publications

MeSH Terms

Conditions

Intermittent Claudication

Interventions

Ramipril

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Peripheral Vascular Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Judith Long
• Organization: Hull University Teaching Hospitals NHS Trust

judith.long3@nhs.net

01482 311918

Study Officials

• Ian Chetter, MD, FRCS

  University of Hull

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2009
• First Posted: December 23, 2009
• Study Start: December 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: December 18, 2025
• Results First Posted: December 18, 2025

Record last verified: 2022-04

Locations

GB (1)