Clinical and Cost Effectiveness of ACE Inhibitor, Ramipril, in Intermittent Claudicants
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by University of Hull.
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
University of Hull
Information provided by:
University of Hull
ClinicalTrials.gov Identifier:
NCT01037530
First received: December 22, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Intermittent Claudicants |
Drug: Ramipril |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official 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 |
Resource links provided by NLM:
Further study details as provided by University of Hull:
Primary Outcome Measures:
- 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 degree incline. [ Time Frame: 0,2,6,24 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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: 0,2,6,24 weeks ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Health economics (cost effectiveness / utility) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 78 |
| Study Start Date: | February 2010 |
| Estimated Study Completion Date: | July 2011 |
| Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Ramipril |
Drug: Ramipril
5 mg/day for 2 weeks then 10 mg/day for 22 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01037530
Contacts
| Contact: Yousef Shahin, MD | yousef.shahin@hey.nhs.uk |
Locations
| United Kingdom | |
| Hull and East Yorkshire Hospitals | Not yet recruiting |
| Hull, Yorkshire, United Kingdom, HU3 2JZ | |
Sponsors and Collaborators
University of Hull
Investigators
| Principal Investigator: | Ian Chetter, MD, FRCS | University of Hull |
More Information
No publications provided
| Responsible Party: | Dr Yousef Shahin, University of Hull |
| ClinicalTrials.gov Identifier: | NCT01037530 History of Changes |
| Other Study ID Numbers: | 05102009, 2009-016600-23 |
| Study First Received: | December 22, 2009 |
| Last Updated: | December 22, 2009 |
| Health Authority: | UK: Research Ethics Committee, Leeds West |
Keywords provided by University of Hull:
|
ACE inhibitors Intermittent claudication Ramipril |
Additional relevant MeSH terms:
|
Angiotensin-Converting Enzyme Inhibitors Ramipril Enzyme Inhibitors Protease Inhibitors Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Antihypertensive Agents Cardiovascular Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 18, 2013