Study of Bosentan and Dapagliflozin to Improve Blood Vessel Function in Adults with Large Vessel Vasculitis in Remission

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.

Dapagliflozin and Endothelin Receptor Antagonism in Large Vessel Vasculitis (DERAIL-LVV)