Active not recruitingPHASE3INTERVENTIONAL

VIRTUOSE : Efficiency of Sildenafil on the Absolute Claudication Distance of Peripheral Arterial Disease Patients With Intermittent Claudication.

This research, called VIRTUOSE, is a major study looking into whether a drug called sildenafil (often used for erectile dysfunction) can improve walking distance for people with Peripheral Artery Disease (PAD). PAD causes leg pain when walking, known as intermittent claudication. Currently, there aren't many medications that effectively improve walking for this condition. The study will give some participants sildenafil and others a dummy pill (placebo) for 24 weeks, in addition to their usual care. Researchers hope that sildenafil could help patients walk further, reducing pain and improving their overall quality of life. This is important as PAD affects millions, and finding better ways to manage symptoms can make a big difference.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Rennes University Hospital

Enrolment target

106

Start

24 Nov 2021

Estimated completion

24 Jun 2026

Peripheral Artery Disease

What is this study about?

Peripheral Artery Disease (PAD) is a common condition where narrowed arteries reduce blood flow to your limbs, most often your legs. This can cause leg pain when you walk, known as 'intermittent claudication.' This pain usually goes away when you rest, but it can stop you from doing everyday activities and significantly impact your quality of life. Millions of people around the world, including many in the UK, live with PAD, and it's important to find effective ways to manage its symptoms.

Currently, the main treatments for claudication focus on improving blood flow, advice to walk regularly, and other medications to manage your heart health. For a long time, there hasn't been a new medication that consistently helps people walk further. This study aims to see if sildenafil, a drug well-known for other uses, could be a new option. Early indications suggest it might help people with PAD walk more easily and further.

The VIRTUOSE study is a significant step in understanding if sildenafil can make a real difference. If successful, it could provide a new way to help people with PAD improve their walking ability, reduce pain, and ultimately lead a more active and fulfilling life. Finding better treatments for this common and often debilitating condition is a high priority for researchers and doctors.

Key takeaways

This study explores sildenafil (Viagra) for walking pain in PAD.
It compares sildenafil to a dummy pill over 24 weeks.
The goal is to improve walking distance and life quality for PAD patients.
Participants will continue their regular PAD treatment.
Regular check-ups and phone calls will monitor your health.
Your safety and well-being are paramount throughout the study.

Who may be eligible?

To join this study, you need to be at least 18 years old and have Peripheral Artery Disease (PAD) that causes leg pain when you walk. Your walking pain should have been stable for at least 4 weeks, despite receiving the best current medical treatments and advice to walk. You should also be able to walk no more than 500 meters on a treadmill when tested.

There are several reasons why you might not be able to join. For instance, if you are already scheduled for surgery to improve blood flow in your legs, or if you have a life-threatening illness, you won't be eligible. Also, if you are pregnant or breastfeeding, or if you have certain heart conditions, very low blood pressure, severe kidney or liver problems, or specific eye conditions, you cannot take part. Additionally, if you are already taking certain medications (like nitrates or some other drugs that interact with sildenafil), you won't be able to participate. The research team will check all these details carefully.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have Peripheral Artery Disease (PAD) causing leg pain when you walk?
Has your walking pain been stable for at least 4 weeks despite current treatments?
Can you walk no more than 500 meters on a treadmill?
Are you NOT scheduled for leg revascularization surgery?
Are you NOT taking nitrates or specific interacting medications (e.g., alpha-blockers, ritonavir)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be randomly assigned to one of two groups, like flipping a coin. One group will receive 140 mg of sildenafil (the active drug) once a day, and the other group will receive a dummy pill (placebo) once a day. Both groups will take their study medication for a total of 24 weeks. This treatment will be in addition to your usual care, including any antiplatelet drugs, cholesterol-lowering medication, and advice to walk.

During the study, you'll have several scheduled phone calls and clinic visits. For the first 4 weeks, you'll take the study drug, and then have a follow-up visit. If everything is fine, you'll continue for another 8 weeks, with phone calls in between. After 12 weeks, you'll have another visit, where the doctors will check your progress and see if you still need other treatments for your legs. If there are no major issues, you'll continue the study drug for another 12 weeks, with more phone calls. Your final visits will be at week 24 (when you stop the study drug) and again at week 48 (24 weeks after stopping the drug) to see how you are doing.

Potential risks and benefits

Participating in this study might offer you the potential benefit of improving your walking ability and reducing the leg pain associated with PAD, especially if sildenafil proves effective. However, as with any medication, there are potential risks and side effects associated with sildenafil, such as headaches, flushing, stomach upset, or changes in vision, among others. The research team will monitor you closely for any side effects throughout the study. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care. Weighing the potential benefits against the potential risks is an important discussion to have with the study team and your own doctor.

Locations (11)

Guillaume MAHE
Verified postcode
Rennes, France
Amiens University Hospital
Verified postcode
Amiens, France
Bordeaux University Hospital
Verified postcode
Bordeaux, France
Caen University Hospital
Verified postcode
Caen, France
Cholet Hospital
Verified postcode
Cholet, France
Groupe Hospitalier Mutualiste de Grenoble
Verified postcode
Grenoble, France
Grenoble University Hospital
Verified postcode
Grenoble, France
Mulhouse Hospital
Verified postcode
Mulhouse, France
Nîmes University Hospital
Verified postcode
Nîmes, France
AP-HP - Hôpital Européen Georges Pompidou
Verified postcode
Paris, France
Hospital Paris Saint-Joseph and Hospital Marie Lannelongue
Verified postcode
Paris, France

Common questions

What is Peripheral Artery Disease (PAD)?

PAD is a condition where narrow arteries reduce blood flow to your limbs, usually your legs, causing pain or discomfort, especially when you walk.

What is 'intermittent claudication'?

This is the medical term for leg pain or discomfort that occurs when you walk but gets better when you rest. It's a common symptom of PAD.

What is sildenafil?

Sildenafil is a medication commonly known as Viagra. It works by relaxing blood vessels, which can increase blood flow to certain areas of the body.

What is a 'placebo'?

A placebo is a dummy pill that looks like the active drug but contains no medicine. It's used in studies to compare the effects of the active drug against no treatment.

Will I still get my usual medication for PAD?

Yes, participation in this study means you will continue to receive your usual medical care and medications for PAD, in addition to the study drug or placebo.