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Enavogliflozin Outcome Trial in Functional Tricuspid Regurgitation

Study acronym: EVENT
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Recruiting to Active, Not Recruitingv7 Show 4 more changesShow less
    • Enrollment target: estimated 540 to confirmed 541
    • Primary completion date: Dec 2026 to Jun 2027
    • Study completion date: Oct 2027 to Aug 2027
    • Site details revised at 5 of 5 sites
  2. Primary completion date: Apr 2026 to Dec 2026v6
  3. Start date changed from estimate of Oct 2023 to Oct 25, 2023v5
  4. Site details revised at 1 of 5 sitesv4
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 5
    v3
  6. Re-verified, no change to tracked fieldsv2
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Asan Medical Center
92 trials monitored
See 1 trial at risk
Heart Disease
8,786 trials monitored
See 412 trials at risk
Heart Failure
1,995 trials monitored
See 111 trials at risk
The Enavogliflozin Outcome Trial in Functional Tricuspid Regurgitation (EVENT) was designed to examine the hypothesis that, compared with placebo, therapy with the SGLT2 inhibitor enavogliflozin would improve clinical and echocardiographic outcomes in heart failure (HF) patients with functional tricuspid regurgitation (TR) and preserved left ventricular ejection fraction (LVEF). The primary objective of the EVENT study is to test the hypothesis that, compared with placebo, therapy with enavogliflozin for 18 months would improve a composite of cardiovascular events or worsening of TR on follow-up echocardiography in HF patients with functional TR and preserved LVEF. The secondary objective is to examine whether enavogliflozin is effective in reduction of renal events and tricuspid regurgitation, and to evaluate whether beneficial effects of enavogliflozin on primary outcomes are associated with reduction of all-cause mortality.
Trial Details
NCT Number NCT06027307
Lead Sponsor Asan Medical Center
Collaborators: Daewoong Pharmaceutical Co. LTD.
Conditions
(from sponsor)		 Tricuspid Regurgitation, Heart Failure With Preserved Ejection Fraction
Related terms Tricuspid Valve Insufficiency
Enrollment 541 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov