Phase 4
N=33
Clinical and Cost Effectiveness of ACE Inhibitor, Ramipril, in Intermittent Claudicants
Intermittent Claudicants
Bottom Line
View on ClinicalTrials.gov: NCT01037530 ↗Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Dec 2025
Primary outcome: Primary: Maximum Walking Distance (MWD). — 137; 143 Metres
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Ramipril (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hull University Teaching Hospitals NHS Trust
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Walking Distance (MWD). |
137; 143 | — |
| SECONDARY 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) |
— | — |
| SECONDARY Quality of Life: a) Generic - Measured Using the SF36, SF8 and EuroQol (EQ5D) Instruments b) Disease Specific - Measured Using the VascuQol |
— | — |
| SECONDARY 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) |
— | — |
| SECONDARY 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) |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY Health Economics (Cost Effectiveness / Utility) |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
- Patients with unilateral or bilateral intermittent leg claudication which was stable for the last 6 months.
- Patients with ABPI 2 weeks and/or a resting ankle pressure 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 160mmHg systolic or 100mmHg diastolic on 3 separate readings measured after 10 minutes rest on 2 separate occasions
- Recent ( 250 micromol/l)
Data sourced from ClinicalTrials.gov (NCT01037530). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.