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

Study acronym: DERAIL-LVV
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Interventions: Bosentan (Drug) to Bosentan and dapagliflozin (Drug) Study description expanded, about 195 words · Study title revised · Eligibility criteria expanded, about 2 wordsv4 Show 3 more changesShow less
    • Study description expanded, about 195 words
    • Study title revised
    • Eligibility criteria expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  2. Minor Study title expanded, about 1 wordv3 See this version in full on ClinicalTrials.gov ↗
  3. Minor Re-verified, no change to tracked fieldsv2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06887062
Lead Sponsor University of Edinburgh
Conditions Large Vessel Vasculitis, Giant Cell Arteritis (GCA), Takayasu Arteritis
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov