Reduced Cardiovascular Morbi-mortality by Sildenafil in Patients With Arterial Claudication

Study Overview
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Brief Summary
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Sildenafil has shown potential effects both on vasodilator mechanisms and as an inhibitor of the NO/GMPc Pain activation. The investigators aim at estimating the benefit of sildenafil in term of morbi-mortality in patients with arterial claudication on a multicenter prospective double blind study.

Detailed Description
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Eligible patients will ask to participate after oral and written information. Evaluation of walking capacity (self reported and treadmill measured), co-morbid condition and quality of life (WELCH, SF-36, Edinburg) will be performed at inclusion, after the first dose and at 3 months of oral treatment through sildenafil 100mg/day or placebo from inclusion to 3 months. Indication for revascularisation will be evaluated at 3 months according to symptoms and walking capacity according to the Rutherford classification. Primary endpoint is the proportion of patients showing either a fatal events (cardio-vascular or noncardiovascular) or hospitalisation for non fatal cardiovascular events at 6 and 9 months follow up from inclusion.

Official Title
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Reduction de la Morbi-mortalité Cardiovasculaire Chez l'artériopathe Claudicant Par le Sildenafil

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Drug: Sildenafil
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ABI<0.90 Vascular type claudication stable walking impairment for at least 3 months Optimal cardiovasc treatment (Anti-platelet, HMGCoA-Inh, ACE-Inh or AT2 inh) Age > 30 years Exclusion Criteria: Refuse to participate Administrative protection Severe renal (clearance < 30 ml/min) or hepatic (Child-Pugh C) failure

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treated group<br>Sildenafil, oral, 100mg per day | Drug: Sildenafil<br>* 100 mg per day<br>* Other names: Viagra or revatio;|
| Placebo Comparator: Control group<br>placebo oral | Drug: Placebo<br>* Placebo with same presentation as the active drug<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbi-mortality : combined criterion (Cardiovascular fatal and non fatal event Improvement of 1 stage) |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life Questionnaire |  | 3, 6 and 9 months | 
| Safety and secondary effects (Headache, Hypotension) (Proportion of Participants with Adverse Event) | Proportion of Participants with Adverse Events (sildenafil vs. placebo) | 3, 6 and 9 months | 
| Walking capacity (treadmill test) | treadmill test | 3, 6 and 9 months | 
| Proportion of revascularized patients | Revascularisation | 6 and 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Claudication, Maximal walking distance, Morbi-mortality