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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Edinburgh

About this trial

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

Qualifiers

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

Disqualifiers

Age <18 years

Active LVV

Any organ transplant recipients

A requirement for any medications that are contra-indicated whilst taking Bosentan or dapagliflozin

Trial design

Treatments tested in this trial

  • Bosentan and dapagliflozin

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators