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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

Large vessel vasculitis 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. The investigators plan to assess blood vessel function in those with LVV and participants without LVV. Participants with LVV will then be given Bosentan for 6 weeks to evaluate its impact on blood vessel function.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• A diagnosis of large vessel vasculitis that has been in remission for ≥ 6 months.

Locations
Other Locations
United Kingdom
University of Edinburgh
RECRUITING
Edinburgh
Contact Information
Primary
Alex Armstrong
a.armstrong-9@sms.ed.ac.uk
+447445695898
Time Frame
Start Date: 2025-03-21
Estimated Completion Date: 2027-07-01
Participants
Target number of participants: 60
Treatments
Experimental: 30 participants with large vessel vasculitis in disease remission
* Participants will undergo a forearm blood flow study where forearm vasodilatation will be assessed in response to acetylcholine (7.5, 15 and 30ug/min) and sodium nitroprusside (1, 2 and 4ug/min).~* Participants will also receive bradykinin (100, 300 and 1000pmol/min) in order to assess tPA release to measure fibrinolytic capacity.~* 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.~* 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.
No_intervention: 30 age-, sex- and cardiovascular disease risk-matched control participants
* Participants will undergo a forearm blood flow study where forearm vasodilatation will be assessed in response to acetylcholine (7.5, 15 and 30ug/min) and sodium nitroprusside (1, 2 and 4ug/min).~* Participants will also receive bradykinin (100, 300 and 1000pmol/min) in order to assess tPA release to measure fibrinolytic capacity.~* 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.~* These measurements will be compared to the large vessel vasculitis group to assess if there are differences in these measurements.
Sponsors
Leads: University of Edinburgh

This content was sourced from clinicaltrials.gov