Bosentan and dapagliflozin for blood vessel function in large vessel vasculitis
Tests bosentan and dapagliflozin on blood vessel function in people with large vessel vasculitis.
Key facts
- Who runs it
- University of Edinburgh
- Where
- United Kingdom1 site in 1 countryChoose a country to see its sites
- Trial code
- Registry title
- Dapagliflozin and Endothelin Receptor Antagonism in Large Vessel Vasculitis (DERAIL-LVV)
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 60 people, planned
- Started
- 21 Mar 2025
- Expected to end
- 1 Jul 2027
- Type of study
- Interventional, 2 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- Bosentan and dapagliflozin
- Record updated
- 14 January 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with large vessel vasculitis that has been in remission for at least 6 months. It also takes control participants without the disease, of similar age, sex and heart disease risk.
- Age
- 18 years and older
- Sex
- All sexes
- Disease stage
- Large vessel vasculitis (such as giant cell arteritis or Takayasu arteritis) in remission for ≥ 6 months. Active disease cannot join.
Main reasons for not taking part
- Active large vessel vasculitis
- Having received any organ transplant
- Congestive heart failure
- Needing medicines that cannot be taken with Bosentan or dapagliflozin
- Being pregnant or breastfeeding, or planning a pregnancy during the study
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- A diagnosis of large vessel vasculitis that has been in remission for ≥ 6 months
Who cannot take part
- Any organ transplant recipients
- A requirement for any medications that are contra-indicated whilst taking Bosentan or dapagliflozin
- Participation in another clinical trial for 28 days before or 90 days after the study period
- Congestive cardiac failure
- History of multiple and/or severe (clinical judgement as determined by the Investigator) allergic reactions to drugs, including the study drug, or food
- Age <18 years
- Active LVV
- Patients not medically fit to attend study visits
- Patients without mental capacity or willingness to provide informed consent
- Patients who are pregnant or breast feeding, or those who plan to become pregnant during the study
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 2 groups in the trial
- 30 participants with large vessel vasculitis in disease remissionTreatment being tested
* 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.
Treatment: Bosentan and dapagliflozin
- 30 age-, sex- and cardiovascular disease risk-matched control participantsNo study treatment, for comparison
* 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.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Dapagliflozin and Endothelin Receptor Antagonism in Large Vessel Vasculitis (DERAIL-LVV)
- Plain-language title
- Bosentan and dapagliflozin for blood vessel function in large vessel vasculitisGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 15 November 2026.
- Record updated
- 14 January 2026