Effect of Sildenafil on Walking Distance in Patients with Peripheral Artery Disease

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.

This study tests if the medication Sildenafil can help people with Peripheral Artery Disease walk farther and feel better while receiving their usual treatment.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 220 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Rennes University Hospital (Academic / other)
• Locations: 13 sites (Rennes, Bretagne and 12 other locations)
• Trial ID: NCT03686306 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of Sildenafil in improving the absolute claudication distance in patients suffering from Peripheral Artery Disease (PAD) with intermittent claudication. It is a Phase III, multicenter, randomized, double-blind, placebo-controlled trial where participants will receive either Sildenafil or a placebo for 24 weeks, alongside optimal medical treatment. The study aims to assess the drug's impact on walking capacity and overall tolerance, with follow-up evaluations at specified intervals to monitor progress and side effects.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with stable intermittent claudication due to PAD, who have not improved with optimal medical treatment.

Not a fit: Patients with critical limb ischemia or those already scheduled for revascularization may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly enhance walking ability and quality of life for patients with PAD.

How similar studies have performed: While Sildenafil's use in this context is novel, other studies have shown positive outcomes with similar PDE inhibitors in improving claudication symptoms.

Eligibility criteria

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.

Exclusion Criteria:

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.

Where this trial is running

Rennes, Bretagne and 12 other locations

• Guillaume MAHE — Rennes, Bretagne, France (Recruiting)
• Amiens University Hospital — Amiens, France (Recruiting)
• Bordeaux University Hospital — Bordeaux, France (Recruiting)
• Caen University Hospital — Caen, France (Recruiting)
• Cholet Hospital — Cholet, France (Recruiting)
• Groupe Hospitalier Mutualiste de Grenoble — Grenoble, France (Recruiting)
• Grenoble University Hospital — Grenoble, France (Recruiting)
• Mulhouse Hospital — Mulhouse, France (Suspended)
• Nîmes University Hospital — Nîmes, France (Recruiting)
• AP-HP - Hôpital Européen Georges Pompidou — Paris, France (Recruiting)
• Hospital Paris Saint-Joseph and Hospital Marie Lannelongue — Paris, France (Recruiting)
• Saint-Etienne University Hospital — Saint-Etienne, France (Withdrawn)
• Toulouse University Hospital — Toulouse, France (Withdrawn)

Study contacts

• Study coordinator: Loukman Omarjee, MD

Conditions Peripheral Artery Disease