Peripheral Arterial Occlusive Disease
Conditions
Brief summary
Efffect of a single dose oral intake of sildenafil Or placebo on the walking capacity on treadmill of PAD patients with claudication
Detailed description
Sildenafil 100mg or Placebo Oral intake 2 hours before the treadmill test Safety and security control throughout the period of drug efficacy (approx 4 hours) Evaluation of maximal walking distance for a constant load treadmill test (3.2 kml/h 10% slope)
Interventions
DRUGPlacebo, Oral intake single dose
Measurement of maximal walking distance on a constant load treadmill test (3.12 km/ 10% slope)
DRUGSildenafil 100mg single oral dose
Measurement of maximal walking distance on a constant load treadmill test (3.12 km/ 10% slope)
Sponsors
University Hospital, Angers
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient with peripheral arterial desease stade II * Patient with vascular claudication for at least 3 months * Patient able to perform a treadmill walking test with time to walk \< 5min
Exclusion criteria
* Patient suffering from ischemia * Previous angina or myocardial * Patient treated with nitrates drugs * Patient with severe renal insufficiency * Patient with severe hepatic insufficiency * Patient with hypotension
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Walking duration on treadmill | 2 hours after treatment intake | Treadmill test with consttant load procedure 3.2 km/h H 10% slope up to 15 minutes followed by incremental load according tpo the Bruce protocole thereafter. |
Outcome results
None listed