Enavogliflozin Outcome Trial in Functional Tricuspid Regurgitation

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.

NCT Number	NCT06027307
Lead Sponsor	Asan Medical Center Collaborators: Daewoong Pharmaceutical Co. LTD.
Conditions	Tricuspid Regurgitation, Heart Failure With Preserved Ejection Fraction
Enrollment	541 participants
Start Date	2023-10-25
Primary Completion	2027-06 (estimated)
Study Completion	2027-08 (estimated)
Updated on ClinicalTrials.gov	2025-12-29