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

RecruitingPhase 2Ages 18 Years - anyAllUniversity of Edinburgh
NCT06887062 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 Dapaglifl

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📋 Eligibility rules (as published)
Inclusion Criteria: * A diagnosis of large vessel vasculitis that has been in remission for ≥ 6 months. Exclusion Criteria: * 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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What it tests

  • Bosentan and dapagliflozin
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Where

1 site
University of Edinburgh
Edinburgh, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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