Informations générales (source: ClinicalTrials.gov)
VIRTUOSE : Efficiency of Sildenafil on the Absolute Claudication Distance of Peripheral Arterial Disease Patients With Intermittent Claudication. A Phase III, National, Multicentre, Prospective, Randomised, Double-blind, Placebo-Controlled Trial. (VIRTUOSE)
Interventional
Phase 3
Rennes University Hospital (Voir sur ClinicalTrials)
novembre 2021
juin 2025
29 juin 2024
Peripheral Arterial Disease (PAD) is a highly debilitating disease that affects 202
million people around the world and about 7 million people in France. Morbi-mortality
from cardiovascular events is increased in this population. Intermittent claudication is
defined as a discomfort and/or pain in the legs during walking. It is the most common
clinical feature of PAD.
In claudication, primary therapeutic approach is medical treatment and advice to walk.
Revascularization is only proposed when medical treatment and advice to walk for at least
3 to 6 months have failed to improve symptoms and walking ability.
Optimal medical treatment includes Antiplatelet, Lipid Lowering Drugs, AT2 antagonists /
ACE Inhibitors and advice to walk.
To date, no other drug has provided consistent evidence for functional improvement in
claudication, except for Cilostazol, a type-3 phospho-diesterase inhibitor (PDEi). This
compound has been scarcely used in France due to cost and frequent side effect (Headache,
Flush, Diarrhea, etc.) and was withdrawn as a therapy in 2010.
Sildenafil, a type 5 PDEi, is well tolerated, largely used in impotence and has
interesting clinical delay and duration of action in the concept of a potential use in
claudication. Preliminary data from the literature and unpublished case reports, suggest
that this drug could efficiently improve symptoms and walking capacity in patients with
stage 2 claudication.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Europeen Georges Pompidou | Tristan MIRAULT, MD | Contact (sur clinicalTrials) | |||
| GH PARIS SITE SAINT JOSEPH | Ulrique MICHON-PASTUREL, MD | Contact (sur clinicalTrials) | |||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Amiens University Hospital - Amiens - France | Marie-Antoinette SEVESTRE, MD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Bordeaux University Hospital - Bordeaux - France | Joel CONSTANS, MD | Contact (sur clinicalTrials) | |||
| Caen University Hospital - Caen - France | Damien LANEELLE, MD | Contact (sur clinicalTrials) | |||
| Cholet Hospital - Cholet - France | Cédric FONTAINE, MD | Contact (sur clinicalTrials) | |||
| Grenoble University Hospital - Grenoble - France | Gilles PERNOD, MD | Contact (sur clinicalTrials) | |||
| Groupe Hospitalier Mutualiste de Grenoble - 38000 - Grenoble - France | Benjamin SONNET | Contact (sur clinicalTrials) | |||
| Guillaume MAHE - 35033 - Rennes - Bretagne - France | Guillaume MAHE, MD | Contact (sur clinicalTrials) | |||
| Mulhouse Hospital - Mulhouse - France | Contact (sur clinicalTrials) | ||||
| Nîmes University Hospital - Nîmes - France | Antonia PEREZ MARTIN, MD | Contact (sur clinicalTrials) | |||
| Saint-Etienne University Hospital - Saint-Etienne - France | Contact (sur clinicalTrials) | ||||
| Toulouse University Hospital - Toulouse - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
1. Patient ≥ 18 years old;
2. with peripheral artery disease (ABI ≤ 0.90 or TBI ≤ 0.70 or post-exercise ABI
decrease of 18.5% from rest or ABI Exercise TcPO2 with DROPmin ≤ - 15 mmHg)
reporting stable limiting claudication despite optimal medical treatment
(Antiplatelet / Direct Oral Anticoagulant + Lipid Lowering Drugs + AT2 antagonists /
ACE Inhibitors; unless contra-indication) and advice to walk for at least 4 weeks;
3. with a walking capacity lower or equal to 500 meters on treadmill;
4. affiliation to a social security agency
5. Patient who has understood the protocol and signed the consent form to participate.
1. Patient ≥ 18 years old;
2. with peripheral artery disease (ABI ≤ 0.90 or TBI ≤ 0.70 or post-exercise ABI
decrease of 18.5% from rest or ABI Exercise TcPO2 with DROPmin ≤ - 15 mmHg)
reporting stable limiting claudication despite optimal medical treatment
(Antiplatelet / Direct Oral Anticoagulant + Lipid Lowering Drugs + AT2 antagonists /
ACE Inhibitors; unless contra-indication) and advice to walk for at least 4 weeks;
3. with a walking capacity lower or equal to 500 meters on treadmill;
4. affiliation to a social security agency
5. Patient who has understood the protocol and signed the consent form to participate.
1. Revascularization already decided and scheduled;
2. Critical limb ischemia;
3. Life threatening disease;
4. Contraindication related to Sildenafil:
- Patients treated with nitrates or drugs interfering with the action of
sildenafil
- Ongoing treatment by Ritonavir or alpha-blockers
- Hypersensitivity to sildenafil or any of the excipients (lactose monohydrate)
- Recent history of myocardial infarction or stroke < 3 months
- Severe cardiovascular disorders such as unstable angina, severe cardiac failure
and cardiomyopathy
- Hypotension (Blood pressure < 90/50 mmHg)
- Severe renal or hepatic failure
- Amblyopia
- Loss of vision in one eye because of Non-arterial ischemic Ophtalmic Neuropathy
(NAION)
- Known hereditary degenerative retinal disorders such as retinitis pigmentosa
- Leukemia, Drepanocytosis, Multiple Myeloma
5. Pregnancy or breastfeeding;
6. Subjects under reinforced protection, deprived of liberty by judicial or
administrative decision, hospitalized without consent or admitted to a health or
social care establishment for purposes other than research;
7. Being in an exclusion period for another clinical study or in an ongoing
interventional clinical study.