ENAVOgliflozin Outcome Trial in Patients With Severe Aortic Stenosis After Transcatheter Aortic Valve Replacement
NCT ID: NCT05672836
Last Updated: 2025-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
1040 participants
INTERVENTIONAL
2024-12-18
2027-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Enavogliflozin Group
0.3 mg 1 tablet once daily
Enavogliflozin
0.3 mg 1 tablet once daily
placebo as add-on to standard of care treatment group
Placebo matching enavogliflozin
Standard-of-Care
Standard-of-Care medical therapy plus Enavogliflozin matching placebo
Interventions
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Enavogliflozin
0.3 mg 1 tablet once daily
Standard-of-Care
Standard-of-Care medical therapy plus Enavogliflozin matching placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
\* 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.
3. NT-proBNP ≥ 300 pg/mL (for patients without ongoing atrial fibrillation) or NT-proBNP must be ≥ 600 pg/mL (for patients with ongoing atrial fibrillation).
3\. Patients who voluntarily participated in the written agreement
Exclusion Criteria
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.
11. Severe renal insufficiency (eGFR \<30 ml/min/1.73 m2 of body-surface area based on the Modification of Diet in Renal Disease (MDRD) formula) or end-stage renal disease or requiring dialysis at the time of screening.
12. Acute or chronic liver disease with severe impairment of liver function (e.g., ascites, esophageal varices, coagulopathy) or serum levels of transminases or alkaline phosphatase more than two times the upper limit of normal at screening.
13. Chronic pulmonary disease requiring home oxygen, oral steroid therapy or hospitalization for exacerbation within 12 months, or significant chronic pulmonary disease in the Investigator's opinion, or primary pulmonary arterial hypertension.
14. Current or suspicious malignancy or history of malignancy within 5 years
15. Uncontrolled anaemia or haemoglobin \<9g/dl
16. Uncontrolled hypothyroidism or arrhythmia or tachycardia
17. Current ongoing alcoholic or drug addict
18. Subjects with non-cardiac co-morbidities with life expectancy less than 12 months
19. Planned major high-risk operation after transcatheter aortic valve replacement (TAVR)
20. Women of childbearing age who have not reached a consensus on the use of highly effective contraception. Pregnancy or breastfeeding.
21. Participation in other clinical trials, However, where at least one or more conditions are satisfied, it could be an exception according to an investigator's discretion;
* Participating in the observational study expected no effect on the safety and/or effectiveness evaluation of this trial.
* Screening failed before any interventional factor is involved.
* Participants who have completed their involvement in clinical trials and have surpassed a 4-week period since their last administration of the investigational drug.
* Participated in academic trials like strategic or medical device comparison studies conducted under standard therapy provided that there is no additional risk or a specific procedure to a subject and no interference between this trial and other studies.
19 Years
ALL
No
Sponsors
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CardioVascular Research Foundation, Korea
OTHER
Daewoong Pharmaceutical Co. LTD.
INDUSTRY
Duk-Woo Park, MD
OTHER
Responsible Party
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Duk-Woo Park, MD
Professor, Cardiology, Asan Medical Center Heart Institute, Valvular Heart Disease Center, Ischemic Heart Disease Center
Principal Investigators
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Seung-jung Park, MD
Role: STUDY_CHAIR
Professor, Cardiology, Asan Medical Center Heart Institute, Valvular Heart Disease Center, Ischemic Heart Disease Center
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Young-jin Choi, MD
Role: primary
Jae-seok Bae, MD
Role: primary
Jin-bae Lee, MD
Role: primary
Chul-hyun Lee, MD
Role: primary
Dong-heon Yang, MD
Role: primary
Woong Kim, MD
Role: primary
Pil-sang Song, MD
Role: primary
Man-won Park, MD
Role: primary
Han-bit Park, MD
Role: primary
Ju-han Kim, MD
Role: primary
Seong-wook Kwon, MD
Role: primary
Woong-cheol Kang, MD
Role: primary
Rak-kyoung Choi, MD
Role: primary
Sang-don Park, MD
Role: primary
Ik-joon Choi, MD
Role: primary
Yong-rak Cho, MD
Role: primary
Tae-hyun Yang, MD
Role: primary
Han-cheol Lee, MD
Role: primary
In-ho Chae, MD
Role: primary
Duk-woo Park, MD
Role: primary
In-sook Kang, MD
Role: primary
Sang-hoon Shin, MD
Role: primary
Young-hyo Lim, MD
Role: primary
Bum-seong Kim, MD
Role: primary
Chul-woong Yoo, MD
Role: primary
Cheol-ung Choi, MD
Role: primary
Woo-young Jeong, MD
Role: primary
Jeong-hoon Lee, MD
Role: primary
Sung-ho Hur, MD
Role: primary
Sung-hoon Park, MD
Role: primary
Kyoung-min Park, MD
Role: primary
Other Identifiers
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AMCCV2023-01
Identifier Type: -
Identifier Source: org_study_id
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