Peripheral Arterial Disease
Conditions
Keywords
Claudication, Maximal walking distance, Morbi-mortality
Brief summary
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
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.
Interventions
DRUGSildenafil
100 mg per day
DRUGPlacebo
Placebo with same presentation as the active drug
Sponsors
University Hospital, Angers
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Morbi-mortality : combined criterion (Cardiovascular fatal and non fatal event Improvement of 1 stage) | 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life Questionnaire | 3, 6 and 9 months | — |
| Safety and secondary effects (Headache, Hypotension) (Proportion of Participants with Adverse Event) | 3, 6 and 9 months | Proportion of Participants with Adverse Events (sildenafil vs. placebo) |
| Walking capacity (treadmill test) | 3, 6 and 9 months | treadmill test |
| Proportion of revascularized patients | 6 and 9 months | Revascularisation |
Countries
France
Contacts
Primary Contactpierre ABRAHAM, MD, PhD
Outcome results
None listed