drugset / Trial / NCT06887062

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

NCT06887062

Phase 2 Recruiting 60 enrolled University of Edinburgh
Non-randomizedSingle-groupOpen-labelTreatment

Summary

Large vessel vasculitis (LVV) is a disease that causes damage to blood vessels. This damage to blood vessels can increase the risk of patients with LVV developing cardiovascular disease, including heart attacks and strokes. A chemical produced in the body called endothelin may contribute to this increase in cardiovascular disease risk by causing the vessels to stiffen and blood pressure to increase. It has previously been shown that by blocking the effects of endothelin, vessel stiffness and blood pressure improve. Bosentan is a tablet that blocks the effects of endothelin. Dapagliflozin is a sodium-glucose co-transporter 2 inhibitor that has been shown to improve blood vessel function and stiffness in patients with diabetes. The investigators plan to assess blood vessel function in those with LVV and participants without LVV. Participants with LVV will be given Bosentan and Dapagliflozin for 6 weeks, followed by Dapagliflozin for 4 weeks, to evaluate their impact on blood vessel function.

Timeline

Start
2025-03-21
Primary completion
2027-07-01
Completion
2027-07-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Bosentan Other / unclassified 62.5 mg
Subject Dapagliflozin Small molecule 10 mg