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
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by University of Hull

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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:
Ramipril
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014