Actively Recruiting
ENAVOgliflozin Outcome Trial in Patients With Severe Aortic Stenosis After Transcatheter Aortic Valve Replacement
Led by Duk-Woo Park, MD · Updated on 2025-12-15
1040
Participants Needed
31
Research Sites
119 weeks
Total Duration
On this page
Sponsors
D
Duk-Woo Park, MD
Lead Sponsor
C
CardioVascular Research Foundation, Korea
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
ENAVOgliflozin Outcome Trial in Patients With Severe Aortic Stenosis After Transcatheter Aortic Valve Replacement
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 19 years or older with symptomatic aortic stenosis who had a successful transcatheter aortic valve replacement (TAVR).
- Heart failure with preserved or mildly reduced ejection fraction (LVEF 40% or higher).
- Evidence of structural heart disease including left ventricular hypertrophy or left atrial enlargement.
- NT-proBNP level 300 pg/mL or higher without atrial fibrillation, or 600 pg/mL or higher with atrial fibrillation.
- Written informed consent to participate in the study.
You will not qualify if you...
- Acute worsening of heart failure requiring intravenous treatment or mechanical support after TAVR.
- Use of SGLT2 inhibitors within 4 weeks prior to randomization.
- Allergy, intolerance, or hypersensitivity to SGLT2 inhibitors.
- Heart failure with reduced ejection fraction (LVEF less than 40%).
- Type 1 diabetes or diabetic ketoacidosis.
- Chronic or recurrent urinary tract infections.
- Stroke or mini stroke within 12 weeks before enrollment.
- Persistent low blood pressure or very high blood pressure despite treatment.
- Heart failure caused by specific heart diseases like amyloid or sarcoid.
- Severe kidney problems or dialysis.
- Severe liver disease or abnormal liver function tests.
- Chronic lung disease needing oxygen or steroids or recent hospitalization.
- Current or suspected cancer or cancer history within 5 years.
- Uncontrolled anemia or certain thyroid or heart rhythm disorders.
- Ongoing alcohol or drug addiction.
- Other serious health conditions with life expectancy under 12 months.
- Planned major high-risk surgery after TAVR.
- Women of childbearing age not using effective contraception, pregnancy, or breastfeeding.
- Participation in other clinical trials unless meeting specific exceptions by investigator discretion.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 31 locations
1
Bucheon Sejong Hospital
Bucheon-si, South Korea
Actively Recruiting
2
Gyeongsang National University Changwon Hospital
Changwon, South Korea
Actively Recruiting
3
Daegu Catholic University Medical Center
Daegu, South Korea
Actively Recruiting
4
Keimyung University Dongsan Medical Center
Daegu, South Korea
Actively Recruiting
5
Kyungpook National University Hospital
Daegu, South Korea
Actively Recruiting
6
Yeungnam University Medical Center
Daegu, South Korea
Not Yet Recruiting
7
Chungnam National University Hospital
Daejeon, South Korea
Actively Recruiting
8
The Catholic University of Korea, Daejeon ST. Mary's Hospital
Daejeon, South Korea
Actively Recruiting
9
Gangneung Asan Hospital
Gangneung, South Korea
Actively Recruiting
10
Chonnam National University Hospital
Gwangju, South Korea
Actively Recruiting
11
Inje University Ilsan Paik Hospital
Ilsan, South Korea
Actively Recruiting
12
Gachon University Gil Hospital
Incheon, South Korea
Actively Recruiting
13
Incheon Sejong Hospital
Incheon, South Korea
Actively Recruiting
14
Inha University Hospital
Incheon, South Korea
Actively Recruiting
15
The Catholic University of Korea, Incheon St. Mary's Hospital
Incheon, South Korea
Actively Recruiting
16
Dong-A Medical Center
Pusan, South Korea
Actively Recruiting
17
Inje University Pusan Paik Hospital
Pusan, South Korea
Actively Recruiting
18
Pusan National University Hospital
Pusan, South Korea
Actively Recruiting
19
Seoul university Bundang hospital
Seongnam-si, South Korea
Not Yet Recruiting
20
Asan Medical Center
Seoul, South Korea
Actively Recruiting
21
Ewha Womans University Mokdong Hospital
Seoul, South Korea
Actively Recruiting
22
Ewha Womans University Seoul Hospital
Seoul, South Korea
Actively Recruiting
23
Hanyang University Seoul Hospital
Seoul, South Korea
Actively Recruiting
24
Konkuk University Medical Center
Seoul, South Korea
Actively Recruiting
25
Korea University Anam Hospital
Seoul, South Korea
Actively Recruiting
26
Korea University Guro Hospital
Seoul, South Korea
Actively Recruiting
27
SNU Boramae Medical Center
Seoul, South Korea
Actively Recruiting
28
The Catholic Univ. of Korea Eunpyeong St. Mary's hospital
Seoul, South Korea
Actively Recruiting
29
The Catholic University of Korea, ST. Vincent's Hospital
Suwon, South Korea
Actively Recruiting
30
Uijeongbu Eulji Medical Center, Eulji University
Uijeongbu-si, South Korea
Not Yet Recruiting
31
Ulsan University Hospital
Ulsan, South Korea
Actively Recruiting
Research Team
J
Jeong-youn Bae, Project manager
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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