ETA and AT1 Antagonism in ANCA-vasculitis (SPARVASC)
This study, called SPARVASC, investigates a new tablet, sparsentan, for people with ANCA-associated vasculitis. This condition damages blood vessels and increases the risk of heart attacks and strokes. A chemical called 'endothelin' can make blood vessels stiff and raise blood pressure. Sparsentan blocks endothelin and lowers blood pressure. Researchers want to see if taking sparsentan for 6 weeks can help improve blood vessel health over a longer period. They will compare it to another blood pressure lowering drug, irbesartan, to understand if the benefits come from blocking endothelin specifically. The goal is to find better ways to protect the heart and blood vessels in people with vasculitis.
At a glance
What is this study about?
ANCA-associated vasculitis is a condition where the body's immune system mistakenly attacks its own blood vessels. This can lead to damage in various organs. While treatments have improved over the years for the vasculitis itself, unfortunately, people with this condition still face a much higher risk of serious heart problems and strokes. In fact, heart and blood vessel disease is a common cause of death for people with vasculitis who are otherwise stable.
Our blood vessels produce a chemical called 'endothelin'. High levels of endothelin can cause blood vessels to become stiff, raise blood pressure, and contribute to problems like heart attacks and strokes. Previous research has shown that temporarily blocking endothelin can help improve blood vessel stiffness and function. This study wants to find out if we can keep these benefits going for a longer time by blocking endothelin with a daily tablet.
We are testing a new tablet called sparsentan. Sparsentan works in two ways: it blocks the effects of endothelin and also helps lower blood pressure. To understand if the positive effects of sparsentan are specifically due to blocking endothelin, we will compare it to another existing blood pressure tablet called irbesartan. Irbesartan lowers blood pressure but doesn't block endothelin. By comparing these two treatments, we hope to learn more about how to protect the heart and blood vessels for people living with ANCA-associated vasculitis.
Key takeaways
- This study aims to improve heart and blood vessel health in people with ANCA-associated vasculitis.
- It tests a new drug, sparsentan, which targets blood vessel stiffness and high blood pressure.
- The study compares sparsentan to another blood pressure drug, irbesartan.
- Participation involves taking daily medication for 6 weeks and having detailed blood vessel tests.
- The goal is to find better long-term solutions for managing cardiovascular risks in vasculitis patients.
Who may be eligible?
To be considered for this study, you must be 18 years old or older and have a confirmed diagnosis of ANCA-associated vasculitis. Your vasculitis needs to have been quiet, or in remission, for at least six months. This means you won't have active symptoms and will be on a low dose of prednisolone (if any) or other treatments.
We'll also check your kidney function to make sure it meets specific levels. For women who could become pregnant, you'll need to agree to use effective contraception throughout the study and have a negative pregnancy test before starting.
You won't be able to join if you have active vasculitis, severe uncontrolled high blood pressure, serious liver or heart conditions like congestive heart failure, or if you've had an organ transplant. People on dialysis or those who can't attend study visits for medical reasons are also not suitable for this particular study.
- Are you 18 years old or older?
- Has your ANCA-associated vasculitis been stable and in remission for at least 6 months?
- Do you have good enough kidney function (as assessed by your doctor and study team)?
- Are you able to attend all clinic visits and assessments for the study?
- Do you have any severe heart, liver conditions, or uncontrolled high blood pressure?
- Are you currently on dialysis or have had an organ transplant?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you will be randomly assigned to receive either sparsentan or irbesartan tablets once a day for six weeks. This is a "double-blind" study, meaning neither you nor the study team will know which tablet you are taking. Before starting, and again after the six weeks of treatment, you will have a special test called a "forearm blood flow study." This involves small measurements on your arm to check how your blood vessels are working. There will also be a few other visits for blood tests and health checks. The total time you'd be involved in the study would be around 7-8 weeks, including the treatment period and follow-up assessments.
Potential risks and benefits
Locations (1)
- Centre for Cardiovascular Science, Queen's Medical Research Institute, 47 Little France CrescentEdinburgh, United Kingdom
Common questions
What is ANCA-associated vasculitis?
It's a rare condition where your immune system attacks blood vessels, causing inflammation and damage.
Why are you studying heart problems in vasculitis patients?
People with vasculitis have a higher risk of heart attacks and strokes, even when their vasculitis is stable, so we need better ways to protect them.
What is sparsentan?
Sparsentan is a tablet that blocks a chemical called endothelin, which can stiffen blood vessels, and also helps lower blood pressure.
Will I know which drug I'm taking?
No, it's a 'double-blind' study, meaning neither you nor the doctors will know which tablet you're receiving until the study is over.
How long will I take the study medicine?
You will take the study medicine once a day for six weeks.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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