Loading clinical trials...

ENAVOgliflozin Outcome Trial in Patients With Severe Aortic Stenosis After Transcatheter Aortic Valve Replacement | Clinical Trials | Clareo Health

RECRUITINGPHASE4

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

A Randomized, Double-Blind, Placebo-controlled Trial to Evaluate Efficacy and Safety of a Novel Sodium-Glucose Cotransporter 2 Inhibitor, Enavogliflozin Compared to Placebo on Reducing Major Cardiovascular Events or Worsening Heart Failure in Patients With Severe Aortic Stenosis Who Underwent Transcatheter Aortic Valve Replacement (TAVR) and With Heart Failure With Preserved Ejection Fraction (HFpEF)

NCT05672836•Duk-Woo Park, MD

View on ClinicalTrials.gov

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.

Eligibility

Age

19 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1\. Patients aged ≥19 with symptomatic aortic stenosis who underwent successful transcatheter aortic valve replacement (TAVR)\* (either native valve or valve in valve with any approved/marketed device).
•\* A successful TAVI is defined as device success according to the VARC-2(Valve Academic Research Consortium 2) and VARC-3 criteria:
•1. correct positioning of a single prosthetic heart valve into the proper anatomical location AND
•2. intended performance of the prosthetic heart valve (mean aortic valve gradient \<20 mmHg, peak velocity \<3 m/s, no moderate or severe prosthetic valve regurgitation) AND
•3. absence of periprocedural complications (any type of stroke, life-threatening bleeding, acute coronary artery obstruction requiring intervention, major vascular complication requiring intervention, unresolved acute valve thrombosis, or any requirement of a repeat procedure).
•2\. Heart Failure with Mildly Reduced or Preserved Ejection Fraction
•1. Left ventricular ejection fraction (LVEF) ≥40%
•2. structural heart disease\_Left ventricular hypertrophy (LVH) or Left atrial enlargement
•A. Left ventricular hypertrophy (LVH) with septal thickness or posterior wall thickness ≥ 1.1 cm or
•B. Left atrial (LA) enlargement with at least one of the following: LA width (diameter) ≥3.8 cm or LA length ≥ 5.0 cm, or LA area ≥ 20cm2, or LA volume ≥ 55mL or LA volume index ≥ 29mL/m.
+2 more criteria

Exclusion Criteria

•1. Acute decompensated Heart Failure (exacerbation of chronic Heart Failure) requiring intravenous diuretics, vasodilators, inotropic agents, or mechanical support, or hemodynamic instability following the transcatheter aortic valve replacement procedure.
•2. Currently receiving therapy with an SGLT2 inhibitor within 4 weeks prior to randomization; discontinuation of current use of SGLT2 inhibitor for the purposes of study enrolment is not permitted.
•3. Known allergy, hypersensitivity, or previous intolerance to an SGLT2 inhibitors.
•4. HF with reduced ejection fraction (LVEF \<40%).
•5. Type 1 diabetes mellitus or diabetes ketoacidosis.
•6. Chronic cystitis and/or recurrent urinary tract infection (≥2 times within 1 year).
•7. Stroke or transient ischemic attack within 12 weeks prior to enrollment.
•8. Symptomatic persistent hypotension and/or a systolic blood pressure (SBP) \< 95 mm Hg at screening or at randomization.
•9. SBP ≥180 mmHg irrespective of treatment or SBP ≥160 mmHg with at least ≥3 antihypertensive drugs at screening or randomization.
•10. Heart failure due to any of the following causes; known infiltrative cardiomyopathy (e.g. amyloid, sarcoid, lymphoma, endomyocardial fibrosis, haemochromatosis, Fabry disease), active myocarditis, constrictive pericarditis, cardiac tamponade, known hypertrophic obstructive cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy/dysplasia (ARVD), or uncorrected primary valvular disease.
+15 more criteria

Locations (31)

Bucheon Sejong Hospital

Bucheon-si, South Korea

Gyeongsang National University Changwon Hospital

Changwon, South Korea

Daegu Catholic University Medical Center

Daegu, South Korea

Keimyung University Dongsan Medical Center

Daegu, South Korea

Kyungpook National University Hospital

Daegu, South Korea

Yeungnam University Medical Center

Daegu, South Korea

Chungnam National University Hospital

Daejeon, South Korea

The Catholic University of Korea, Daejeon ST. Mary's Hospital

Daejeon, South Korea

Gangneung Asan Hospital

Gangneung, South Korea

Chonnam National University Hospital

Gwangju, South Korea

Key Dates

Start Date

December 18, 2024

Primary Completion Date

December 1, 2026

Completion Date

April 1, 2027

Last Updated

December 15, 2025

Enrollment

1,040

ESTIMATED participants

Conditions

Aortic Valve StenosisHeart Failure

Interventions

Enavogliflozin

DRUG

Standard-of-Care

DRUG

Contacts

Jeong-youn Bae, Project manager

CONTACT

82230107259 cvcrc10@amc.seoul.kr

ReDS-guided Decongestion Strategy in Patients Hospitalized for Heart Failure

NCT07484009

Acute Heart Failure (AHF)Heart Failure (for Example, Fluid Overload)+1 more

View study

RECRUITING

ML Score Prediction of Cardiotoxicity in Cancer Patients Receiving Anthracycline Chemotherapy or HER2-Targeted Therapies

NCT07191730

CardiotoxicityHeart Failure+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 15, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

ReDS-guided Decongestion Strategy in Patients Hospitalized for Heart Failure

ML Score Prediction of Cardiotoxicity in Cancer Patients Receiving Anthracycline Chemotherapy or HER2-Targeted Therapies

Post-Dilatation Effect on TAVI Prostheses Expansion

Hemodynamic Monitoring to Prevent Adverse Events foLlowing cardiOgenic Shock Trial

Proof-of-concept of a Behavioral Intervention to Improve the Cardiovascular Health of People Living With HIV

Autologous Induced Pluripotent Stem Cells of Cardiac Lineage for Congenital Heart Disease