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

Launched by UNIVERSITY OF EDINBURGH · Mar 13, 2025

Keywords

ClinConnect Summary

The DERAIL-LVV trial is studying a condition called large vessel vasculitis, which can lead to serious issues like heart attacks and strokes by damaging blood vessels. Researchers believe that a body chemical called endothelin contributes to these problems by making blood vessels stiff and raising blood pressure. This trial will test a medication called Bosentan, which blocks the effects of endothelin, to see if it can improve blood vessel function in people with this condition. Participants with large vessel vasculitis who have been in remission for at least six months will take Bosentan for six weeks and have their blood vessel function monitored.

To be eligible for the study, participants must be between 65 and 74 years old and have a confirmed diagnosis of large vessel vasculitis that has not been active for at least six months. Unfortunately, those with active disease, certain health conditions, or who are pregnant or breastfeeding cannot participate. During the trial, participants can expect regular visits to assess their health and the effects of the medication. This study is currently recruiting participants, and it's important for those interested to speak with their doctor to see if they qualify.

Gender

ALL

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
• • 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