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

NCT05672836 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1040

Last updated 2025-12-15

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Enavogliflozin

0.3 mg 1 tablet once daily

DRUG

Standard-of-Care

Standard-of-Care medical therapy plus Enavogliflozin matching placebo

Sponsors & Collaborators

  • CardioVascular Research Foundation, Korea

    collaborator OTHER

  • Daewoong Pharmaceutical Co. LTD.

    collaborator INDUSTRY

  • Duk-Woo Park, MD

    lead OTHER

Principal Investigators

  • Seung-jung Park, MD · Professor, Cardiology, Asan Medical Center Heart Institute, Valvular Heart Disease Center, Ischemic Heart Disease Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-18
Primary Completion
2026-12-31
Completion
2027-04-30

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05672836 on ClinicalTrials.gov