Dapagliflozin and Endothelin Receptor Antagonism in Large Vessel Vasculitis (DERAIL-LVV)
This study is called DERAIL-LVV and focuses on a condition called Large Vessel Vasculitis (LVV), which includes Giant Cell Arteritis and Takayasu Arteritis. LVV causes damage to blood vessels, making people more likely to have heart attacks and strokes. Previous research suggests that a natural body chemical called endothelin can make this worse by stiffening blood vessels and raising blood pressure. We are testing two medicines: Bosentan, which blocks the effects of endothelin, and dapagliflozin, which has helped improve blood vessel health in other conditions. We want to see if these medicines can improve blood vessel function in people with LVV. Participants with LVV will take both medicines for six weeks, and then only dapagliflozin for four weeks.
At a glance
What is this study about?
Large Vessel Vasculitis (LVV) is a chronic illness where the body's immune system mistakenly attacks its own blood vessels, causing damage and inflammation. This damage can make blood vessels stiff and less able to work properly. Over time, this can lead to serious problems like heart attacks and strokes. Even with current treatments that help manage the initial inflammation, people with LVV still face a higher risk of heart and circulation problems.
Researchers are interested in how a natural body chemical called endothelin might play a part in these problems. When there's too much endothelin, it can make blood vessels stiffen and blood pressure go up. We already know that medicines that block endothelin can help improve blood vessel stiffness. We are also looking at another medicine called dapagliflozin. While primarily used for other conditions, dapagliflozin has shown promise in improving how blood vessels work and reducing stiffness, even in people without diabetes.
This study aims to find out if combining Bosentan (which blocks endothelin) and dapagliflozin can help improve the health and function of blood vessels in people with LVV. By understanding this better, we hope to find new ways to reduce the risk of heart attacks and strokes for people living with LVV. The goal is to see if these medicines can make a meaningful difference in the long-term health of people with this condition.
Key takeaways
- The study explores two medicines, Bosentan and dapagliflozin, for Large Vessel Vasculitis (LVV).
- It aims to improve blood vessel health and reduce the risk of heart problems in LVV.
- Participation involves taking medicines for 10 weeks and attending study visits for health checks.
- People with stable LVV who meet specific criteria are invited to participate.
- The study hopes to find new ways to improve long-term outcomes for those with LVV.
Who may be eligible?
To be considered for this study, you must have a diagnosis of Large Vessel Vasculitis (LVV) and your condition must have been stable and under control for at least the past six months.
There are several reasons why you might not be able to join. You can't be under 18 years old, have active LVV at the moment, or have had an organ transplant. We also can't include you if you're taking any medicines that shouldn't be mixed with Bosentan or dapagliflozin, or if you have severe heart failure.
Additionally, you can't be pregnant or breastfeeding, or planning to become pregnant during the study. You also need to be well enough to attend all study visits and be able to understand and agree to take part. If you've recently participated in another clinical trial, this might also affect your eligibility.
- Have I been diagnosed with Large Vessel Vasculitis (LVV)?
- Has my LVV been stable and in remission for at least 6 months?
- Am I over 18 years old?
- Am I NOT currently pregnant, breastfeeding, or planning to become pregnant during the study?
- Am I NOT taking any medications that might conflict with Bosentan or dapagliflozin?
- Do I feel well enough to attend regular study appointments?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you join this study, your participation will involve several visits over about 10 weeks. Initially, we will test your blood vessel function. Then, you will take both Bosentan and dapagliflozin tablets for six weeks. After that, you will only take dapagliflozin for another four weeks. During your time on the study, you'll have regular appointments where we'll check your health, take blood and urine samples, and assess your blood vessel function to see how the medicines are working. We will provide detailed instructions on how and when to take your study medicines.
Potential risks and benefits
Locations (1)
- University of EdinburghEdinburgh, United Kingdom· Recruiting
Common questions
What is Large Vessel Vasculitis?
It's a condition where your immune system attacks and damages your body's larger blood vessels, which can lead to problems like stiffness and sometimes more serious issues like heart attacks or strokes.
What are Bosentan and dapagliflozin?
Bosentan is a medicine that blocks a natural chemical called endothelin, which can make blood vessels stiff. Dapagliflozin is another medicine that has shown promise in improving how blood vessels work.
How long will I take the study medicines?
You will take both medicines for six weeks, followed by dapagliflozin only for another four weeks, making a total of 10 weeks of treatment in the study.
Will I get 'active' medicine or a dummy pill?
In this specific study, participants with LVV will be given Bosentan and Dapagliflozin. There is no mention of a dummy pill (placebo) for this part of the study.
What kind of tests will I have?
You'll have tests to check your blood vessel function, blood and urine samples, and general health checks at various study visits.
How to find out more
Alex Armstrong
Always speak to your GP or specialist before deciding to take part in a study.
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