[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100584263":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":25,"locations":31,"responsibleParty":46,"collaborators":18,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":55,"sex":56,"minAge":57,"maxAge":18,"enrollmentInfo":58,"targetDuration":18,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":69,"overallStatus":33,"whyStopped":18,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"University of Edinburgh","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"30 participants with large vessel vasculitis in disease remission","EXPERIMENTAL","* Participants will undergo a forearm blood flow study where forearm vasodilatation will be assessed in response to acetylcholine (7.5, 15 and 30ug\u002Fmin) and sodium nitroprusside (1, 2 and 4ug\u002Fmin).\n* Participants will also receive bradykinin (100, 300 and 1000pmol\u002Fmin) in order to assess tPA release to measure fibrinolytic capacity.\n* Participants will also have 24-hour blood pressure measured, as well as measurements of arterial stiffness, choroidal volume and balance of peripheral inflammatory and anti-inflammatory cells.\n* After these baseline measurements have been obtained, the subject will receive 6 week of Bosentan. The participant will undergo the same investigations to compare if measurements differ after treatment.",[13],"Drug: Bosentan and dapagliflozin",{"label":15,"type":16,"description":17,"interventionNames":18},"30 age-, sex- and cardiovascular disease risk-matched control participants","NO_INTERVENTION","* Participants will undergo a forearm blood flow study where forearm vasodilatation will be assessed in response to acetylcholine (7.5, 15 and 30ug\u002Fmin) and sodium nitroprusside (1, 2 and 4ug\u002Fmin).\n* Participants will also receive bradykinin (100, 300 and 1000pmol\u002Fmin) in order to assess tPA release to measure fibrinolytic capacity.\n* Participants will also have 24-hour blood pressure measured, as well as measurements of arterial stiffness, choroidal volume and balance of peripheral inflammatory and anti-inflammatory cells.\n* These measurements will be compared to the large vessel vasculitis group to assess if there are differences in these measurements.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DRUG","Bosentan and dapagliflozin","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.",[9],[26],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},"Alex Armstrong","CONTACT","+447445695898","a.armstrong-9@sms.ed.ac.uk",[32],{"facility":5,"status":33,"city":34,"state":18,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"RECRUITING","Edinburgh","EH16 4TJ","United Kingdom","UK",{"type":39,"coordinates":40},"Point",[41,42],-3.19648,55.95206,{"lat":42,"lon":41},[45],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},{"type":47,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100584263","phase-2-dapagliflozin-and-endothelin-receptor-antagonism-in-large-vessel-vasculitis-derail-lvv-100584263",false,"NCT06887062","Dapagliflozin and Endothelin Receptor Antagonism in Large Vessel Vasculitis (DERAIL-LVV)","DERAIL-LVV","Inclusion Criteria:\n\n* A diagnosis of large vessel vasculitis that has been in remission for ≥ 6 months.\n\nExclusion Criteria:\n\n* Age \\\u003C18 years\n* Active LVV\n* Any organ transplant recipients\n* A requirement for any medications that are contra-indicated whilst taking Bosentan or dapagliflozin\n* Congestive cardiac failure\n* Patients not medically fit to attend study visits\n* Patients without mental capacity or willingness to provide informed consent\n* History of multiple and\u002For severe (clinical judgement as determined by the Investigator) allergic reactions to drugs, including the study drug, or food\n* Patients who are pregnant or breast feeding, or those who plan to become pregnant during the study\n* Participation in another clinical trial for 28 days before or 90 days after the study period",true,"ALL","18 Years",{"count":59,"type":60},60,"ESTIMATED","INTERVENTIONAL",[63],"PHASE2","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.\n\nIt 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.\n\nDapagliflozin is a sodium-glucose co-transporter 2 inhibitor that has been shown to improve blood vessel function and stiffness in patients with diabetes.\n\nThe 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.",[66,67,68],"Large Vessel Vasculitis","Giant Cell Arteritis (GCA)","Takayasu Arteritis",[70,71,72,73,74,75,76,77,78,79],"Large vessel vasculitis","Takayasu arteritis","Giant cell arteritis","Endothelin","Bosentan","Inflammation","Endothelial dysfunction","Dual enodthelin receptor antagonism","dapagliflozin","SGLT2 inhibitor","2026-01-12",{"date":82,"type":83},"2026-01-14","ACTUAL",{"date":85,"type":83},"2025-03-21",{"date":87,"type":60},"2027-07-01",{"name":5,"class":6},1]