Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

VIRTUOSE: Efficiency of sildenafil on the absolute claudication distance of peripheral arterial disease patients with intermittent claudication. A phase III, National, Multicenter, Prospective, Randomized, Double-blind, Placebo-Controlled trial.

This study, called VIRTUOSE, is looking at how well a medicine called sildenafil works for people who have peripheral arterial disease (PAD). PAD causes leg pain, often when walking, because of poor blood flow. The study wants to see if sildenafil helps people walk further without pain. Participants will take either sildenafil or a dummy pill, and their walking ability will be checked on a treadmill over 24 weeks. Researchers will also look at other health measures over 48 weeks to understand the medicine's full effect and safety. It's a large-scale, carefully planned study to get clear answers.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Centre Hospitalier Universitaire De Rennes

Enrolment target

220

Start

01 Oct 2024

Peripheral arterial disease

What is this study about?

This study, called VIRTUOSE, is designed to find out if a medicine called sildenafil can help people who suffer from a condition called peripheral arterial disease (PAD). PAD is when your arteries, especially in your legs, become narrowed or blocked, reducing blood flow. This can cause pain in your legs, particularly when you walk, which often gets better when you rest. This specific type of leg pain is called intermittent claudication.

The main goal of VIRTUOSE is to measure whether sildenafil can help people with PAD walk further on a treadmill before their leg pain stops them. Researchers will check this at the beginning of the study and again after 24 weeks. This will help them understand if the medicine improves walking distance. It's a 'Phase III' study, meaning it's a large, important trial to confirm if the treatment is effective and safe enough for wider use.

To make sure the results are reliable, this is a 'double-blind, placebo-controlled' study. This means some participants will receive sildenafil, and others will receive a dummy pill (placebo), but neither you nor your doctor will know which you are taking. This helps prevent any bias. Researchers will also look at other important health measures over 48 weeks, such as your general health, how your blood vessels are working, and whether the treatment helps prevent more serious health problems.

Key takeaways

The study aims to see if sildenafil helps people with PAD walk further.
It's a large, important study comparing sildenafil to a dummy pill.
Participation involves taking medication and regular check-ups over 48 weeks.
Walking tests on a treadmill are a key part of measuring the treatment's effect.
Both men and women aged 18 and over can be considered for the study.

Who may be eligible?

To join this study, you need to be an adult, 18 years old or older. The study welcomes both men and women.

More detailed criteria about your specific health condition, like your diagnosis of peripheral arterial disease and how severe it is, would be discussed with your doctor. They would also check for any other health issues or medications you're taking that might mean this study isn't right for you.

Essentially, if you are an adult living with leg pain caused by peripheral arterial disease, you might be a suitable candidate to take part.

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.

Am I 18 years old or older?
Have I been diagnosed with peripheral arterial disease (PAD) that causes leg pain when walking?
Am I able to attend regular hospital visits over nearly a year?
Am I able to walk on a treadmill for assessment purposes?

Answer every question to see your result.

What does participation involve?

If you join this study, you'd be asked to take either the study medicine (sildenafil) or a dummy pill regularly for 24 weeks. You wouldn't know which one you're taking. Throughout this time, you would have several hospital visits for health check-ups and tests. These visits would happen at the beginning of the study, and then at weeks 12, 24, and 48.

During these visits, you'd do certain assessments. A key one involves walking on a treadmill to see how far you can go before leg pain stops you. This treadmill test could last up to 15 minutes. You'd also fill out questionnaires about your health and quality of life, and have other tests that look at your blood vessels, breathing, and general circulation. The total observation period for the study is 48 weeks, meaning researchers will continue to follow your health even after you've finished taking the study medicine.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. You might benefit from closer medical monitoring and possibly experience an improvement in your walking distance and leg pain if you receive the active medicine. However, there's also the chance you might receive the dummy pill and not see any direct benefit. Sildenafil, like all medicines, can have side effects, which your doctor would discuss with you. These could include headaches, flushing, indigestion, or changes in vision. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What is peripheral arterial disease (PAD)?

PAD is a common condition where narrowed arteries reduce blood flow to your limbs, most commonly your legs. This can cause leg pain when walking.

What is sildenafil?

Sildenafil is a medicine that helps to relax blood vessels and improve blood flow. It's already used for some other conditions, but this study is checking its effects on PAD.

What does 'double-blind, placebo-controlled' mean?

It means some people get the active medicine and others get a dummy pill, but neither you nor your doctors know which one you're taking. This helps make the study fair and the results more reliable.

What is a 'treadmill test' in this study?

You'll walk on a treadmill, like the one in a gym, to see how far you can go before leg pain stops you. This helps measure if the treatment is helping you walk further.

How long will I be involved in the study?

You'll likely take the study medicine for 24 weeks, and then your health will be checked for another 24 weeks, making a total involvement of 48 weeks.