NCT06887062 Dapagliflozin and Endothelin Receptor Antagonism in Large Vessel Vasculitis (DERAIL-LVV)
| NCT ID | NCT06887062 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Edinburgh |
| Condition | Large Vessel Vasculitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-03-21 |
| Primary Completion | 2027-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2025-03-21 with a primary completion date of 2027-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06887062 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Large Vessel Vasculitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06887062 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06887062 currently recruiting?
Yes, NCT06887062 is actively recruiting participants. Contact the research team at a.armstrong-9@sms.ed.ac.uk for enrollment information.
Where is the NCT06887062 trial being conducted?
This trial is being conducted at Edinburgh, United Kingdom.
Who is sponsoring the NCT06887062 clinical trial?
NCT06887062 is sponsored by University of Edinburgh. The trial plans to enroll 60 participants.