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

Sponsor
Daniel Carradice (Other)
Overall Status
Completed
CT.gov ID
NCT01037530
Collaborator
(none)
33
Enrollment
1
Location
1
Arm
24
Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
33 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, 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
Study Start Date :
Dec 1, 2010
Actual Primary Completion Date :
Dec 1, 2012
Actual Study Completion Date :
Dec 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ramipril

Drug: Ramipril
5 mg/day for 2 weeks then 10 mg/day for 22 weeks

Outcome Measures

Primary Outcome Measures

  1. 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. [0,2,6,24 weeks]

Secondary Outcome Measures

  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) [0,2,6,24 weeks]

  2. 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]

  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) [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) [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 [0,2,6,24 weeks]

  6. Health economics (cost effectiveness / utility) [24 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Hull and East Yorkshire Hospitals Hull Yorkshire United Kingdom HU3 2JZ

Sponsors and Collaborators

  • Daniel Carradice

Investigators

  • Principal Investigator: Ian Chetter, MD, FRCS, University of Hull

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Daniel Carradice, Clinical Lecturer, University of Hull
ClinicalTrials.gov Identifier:
NCT01037530
Other Study ID Numbers:
  • 05102009
  • 2009-016600-23
First Posted:
Dec 23, 2009
Last Update Posted:
Dec 19, 2014
Last Verified:
Dec 1, 2014
Keywords provided by Daniel Carradice, Clinical Lecturer, University of Hull
ACE inhibitors
Intermittent claudication
Ramipril
Additional relevant MeSH terms:
Ramipril

Study Results

No Results Posted as of Dec 19, 2014