Dapagliflozin and Endothelin Receptor Antagonism in Large Vessel Vasculitis (DERAIL-LVV)
University of Edinburgh
60 participants
Mar 21, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria1
- A diagnosis of large vessel vasculitis that has been in remission for ≥ 6 months.
Exclusion Criteria10
- Age \<18 years
- Active LVV
- Any organ transplant recipients
- A requirement for any medications that are contra-indicated whilst taking Bosentan or dapagliflozin
- Congestive cardiac failure
- Patients not medically fit to attend study visits
- Patients without mental capacity or willingness to provide informed consent
- History of multiple and/or severe (clinical judgement as determined by the Investigator) allergic reactions to drugs, including the study drug, or food
- Patients who are pregnant or breast feeding, or those who plan to become pregnant during the study
- Participation in another clinical trial for 28 days before or 90 days after the study period
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Interventions
Participants with LVV will receive Bosentan 62.5 mg twice daily and Dapagliflozin 10 mg once daily for 6 weeks, followed by Dapagliflozin 10 mg once daily for 4 weeks.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06887062