Blocking endothelin to improve blood vessel function in large vessel vasculitis
Dapagliflozin and Endothelin Receptor Antagonism in Large Vessel Vasculitis (DERAIL-LVV)
This study is testing if a medication called Bosentan can improve blood vessel function in people with large vessel vasculitis who have been in remission for at least six months.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Edinburgh Academic / other |
| Locations | 1 site (Edinburgh) |
| Trial ID | NCT06887062 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of Bosentan, a dual endothelin receptor antagonist, on blood vessel function in patients with large vessel vasculitis (LVV) who have been in remission for at least six months. Initially, the study will compare endothelial function between LVV patients and matched controls without the condition. Following this, LVV participants will receive Bosentan for six weeks to evaluate its impact on their vascular health. The primary assessment method will be forearm plethysmography, which is considered the gold standard for measuring endothelial function.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with large vessel vasculitis in remission for at least six months.
Not a fit: Patients with active large vessel vasculitis or those under 18 years old will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved cardiovascular health and reduced complications for patients with large vessel vasculitis.
How similar studies have performed: Previous studies have shown that endothelin receptor blockade can improve vascular function, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Edinburgh
- University of Edinburgh — Edinburgh, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Alex Armstrong
- Email: a.armstrong-9@sms.ed.ac.uk
- Phone: +447445695898
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.