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NCT05672836 · ClinicalTrials.gov record · last posted 2026-06-29

ENAVOgliflozin Outcome Trial in Patients With Severe Aortic Stenosis After Transcatheter Aortic Valve Replacement

Study acronym: ENAVO-TAVR
StatusRecruiting
PhasePhase 4
Started2024-12-18
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from the ClinicalTrials.gov record
The goal of this trial is to to determine whether use of a novel SGLT2 inhibitor, Enavogliflozin 0.3 mg once daily is superior to placebo, when added to standard-of-care, in reducing the composite of major cardiovascular events and Heart Failure events (hospitalization for Heart Failure or urgent Heart Failure visit) among patients who underwent transcatheter aortic valve replacement for severe aortic stenosis and with heart failure with preserved ejection fraction.

Amendment record 9 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 9 times since 2023-01-04; most recent amendment 2026-06-26. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

2024-12-17
Status change Not Yet Recruiting→Recruitingv6
Trial Details
NCT Number NCT05672836
Lead Sponsor Duk-Woo Park, MD
Collaborators: CardioVascular Research Foundation, Korea, Daewoong Pharmaceutical Co. LTD.
Conditions Aortic Valve Stenosis, Heart Failure
Enrollment 1,040 participants
Start Date 2024-12-18
Primary Completion 2028-12 (estimated)
Study Completion 2029-04 (estimated)
Updated on ClinicalTrials.gov 2026-06-29