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ENAVOgliflozin Outcome Trial in Patients With Severe Aortic Stenosis After Transcatheter Aortic Valve Replacement
Sponsor: Duk-Woo Park, MD
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.
Official title: 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)
Key Details
Gender
All
Age Range
19 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1040
Start Date
2024-12-18
Completion Date
2027-04
Last Updated
2025-12-15
Healthy Volunteers
No
Conditions
Interventions
Enavogliflozin
0.3 mg 1 tablet once daily
Standard-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