Actively Recruiting
Dapagliflozin and Endothelin Receptor Antagonism in Large Vessel Vasculitis (DERAIL-LVV)
Led by University of Edinburgh · Updated on 2026-01-14
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Large vessel vasculitis (LVV) is an autoimmune disease that causes inflammatory damage to large blood vessels, which can lead to serious complications like heart failure and stroke. Patients with LVV have an increased risk of cardiovascular disease, possibly due to a chemical called endothelin that causes blood vessels to stiffen and raises blood pressure. Researchers are studying whether blocking endothelin and using another drug that improves vessel function can help improve blood vessel health in people with LVV. In this study, participants with LVV will receive the drug Bosentan, which blocks endothelin receptors, together with Dapagliflozin, a medication that helps improve blood vessel function, for 6 weeks. After this, participants will continue on Dapagliflozin alone for 4 weeks. Blood vessel function will be assessed through tests including forearm blood flow studies and blood pressure measurements. The study also includes a comparison group of people without LVV who will undergo similar assessments but do not receive the medications. Participants will have their blood vessel function measured using venous occlusion plethysmography, along with tests of blood pressure, arterial stiffness, eye microvasculature, and blood cell analysis before and after treatment. The study will track changes from baseline to week 6 in these measures to evaluate the effects of the treatments. The total treatment period for those with LVV is 10 weeks, with close monitoring during and after medication use. Participants will also have assessments to understand fibrinolytic capacity and inflammatory cell balance, helping researchers understand treatment impact on vessel health.
CONDITIONS
Brief Title
Dapagliflozin and Endothelin Receptor Antagonism in Large Vessel Vasculitis (DERAIL-LVV)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- A diagnosis of large vessel vasculitis that has been in remission for 6 months
You will not qualify if you...
- Age less than 18 years
- Active large vessel vasculitis
- Any organ transplant recipient
- Requirement for medications contraindicated with Bosentan or Dapagliflozin
- Congestive cardiac failure
- Medically unfit to attend study visits
- Lacking mental capacity or unwilling to provide informed consent
- History of multiple or severe allergic reactions to drugs or food
- Pregnancy, breastfeeding, or planning pregnancy during the study
- Participation in another clinical trial within 28 days before or 90 days after the study period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 10 weeks
Participants with large vessel vasculitis receive Bosentan and dapagliflozin for 6 weeks, followed by dapagliflozin alone for 4 weeks to assess improvement in blood vessel function and stiffness.
Regular visits during 10 weeks of treatment to assess blood vessel function and safety
Trial Site Locations
Total: 1 location
1
University of Edinburgh
Edinburgh, United Kingdom, EH16 4TJ
Actively Recruiting
Research Team
A
Alex Armstrong
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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