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
This trial accepts healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Bosentan and dapagliflozin
DrugParticipants with LVV will receive Bosentan 62.5 mg twice daily and Dapagliflozin 10 mg once daily for 6 weeks, followed by Dapagliflozin 10 mg once daily for 4 weeks.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: 30 participants with large vessel vasculitis in disease remissionExperimental treatment 1 intervention
Group B: 30 age-, sex- and cardiovascular disease risk-matched control participantsNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change from baseline to week 6 in forearm blood flow
Change from baseline to week 6 in acetylcholine-mediated forearm blood flow vasodilation
Time frame
Before and after 6 weeks of treatmentSecondary outcomes
1
Change from Baseline to week 6 in fibrinolytic capacity
Plasma concentration of tissue plasminogen activator in response to bradykinin will be assessed before and after 6 weeks of intervention
Time frame
Before and after 6 weeks of treatment2
Change from Baseline to week 6 in 24h blood pressure
24-hour ambulatory systolic and diastolic blood pressure will be assessed at baseline and 6 weeks.
Time frame
Before and after 6 weeks of treatment3
Change from baseline to week 6 in arterial stiffness
Arterial stiffness will be assessed using pulse wave velocity as measured using SphygmoCor technology. Percentage change in pulse wave velocity will be compared between baseline and 6 weeks
Time frame
Before and after 6 weeks of treatment4
Change from baseline to week 6 assessment of eye microvasculature using retinal OCT
Choroidal volume will be assessed using optical coherence tomography which will be compared at baseline and 6 weeks
Time frame
Before and after 6 weeks of treatmentSponsors and contacts
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Source ClinicalTrials.gov