RecruitingPhase 4NCT05672836

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)

Sponsor

Duk-Woo Park, MD

Enrollment

1,040 participants

Start Date

Dec 18, 2024

Study Type

INTERVENTIONAL

Conditions

Heart Failure Aortic Valve Stenosis

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

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether enavoflozin — a medication in the same family as diabetes drugs like empagliflozin — improves heart outcomes in patients with severe aortic stenosis (a narrowing of the main heart valve) who have already had TAVR, a minimally invasive procedure to replace the heart valve without open-heart surgery. **You may be eligible if...** - You are 19 or older - You have symptomatic severe aortic stenosis and have successfully undergone TAVR (transcatheter aortic valve replacement) - Your replacement valve is working well (good function confirmed on imaging) **You may NOT be eligible if...** - You have Type 1 diabetes or severe kidney disease (which makes this drug class unsafe) - You had complications during your TAVR procedure - You have other conditions that would interfere with the study drug - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEnavogliflozin

0.3 mg 1 tablet once daily

DRUGStandard-of-Care

Standard-of-Care medical therapy plus Enavogliflozin matching placebo

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

Inje University Ilsan Paik Hospital

Ilsan, South Korea

Gachon University Gil Hospital

Incheon, South Korea

Incheon Sejong Hospital

Incheon, South Korea

Inha University Hospital

Incheon, South Korea

The Catholic University of Korea, Incheon St. Mary's Hospital

Incheon, South Korea

Dong-A Medical Center

Pusan, South Korea

Inje University Pusan Paik Hospital

Pusan, South Korea

Pusan National University Hospital

Pusan, South Korea

Seoul university Bundang hospital

Seongnam-si, South Korea

Asan Medical Center

Seoul, South Korea

Ewha Womans University Mokdong Hospital

Seoul, South Korea

Ewha Womans University Seoul Hospital

Seoul, South Korea

Hanyang University Seoul Hospital

Seoul, South Korea

Konkuk University Medical Center

Seoul, South Korea

Korea University Anam Hospital

Seoul, South Korea

Korea University Guro Hospital

Seoul, South Korea

SNU Boramae Medical Center

Seoul, South Korea

The Catholic Univ. of Korea Eunpyeong St. Mary's hospital

Seoul, South Korea

The Catholic University of Korea, ST. Vincent's Hospital

Suwon, South Korea

Uijeongbu Eulji Medical Center, Eulji University

Uijeongbu-si, South Korea

Ulsan University Hospital

Ulsan, South Korea

View Full Details on ClinicalTrials.gov

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