Ireland
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Recruiting Phase 4

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

NCT05672836 · tracked via the Priya Life Science South Korea tracker
Sponsor
Duk-Woo Park, MD
Phase
Phase 4
Started
2024-12-18
Last updated
2026-06-29

Condition(s) studied

Aortic Valve StenosisHeart Failure

Investigational drug(s) / intervention(s)

Enavogliflozin →Standard-of-Care

Enavogliflozin: 0.3 mg 1 tablet once daily

Standard-of-Care: Standard-of-Care medical therapy plus Enavogliflozin matching placebo

Study 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

Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
No
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. 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: 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. 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.

Primary outcome measure(s)

  • Time from randomization to first occurrence of a composite of major adverse cardiovascular events* or hospitalization for heart failure — 12 months
    Time from randomization to the first occurrence of a composite of major adverse cardiovascular events\* or hospitalization for heart failure at 12 months after randomization. \*Major adverse cardiovascular events included death from any causes, nonfatal myocardial infarction, or nonfatal stroke. A composite endpoint is an endpoint that is a combination of multiple clinical endpoints. An event is considered to have occurred if any one of several different events is observed.

Trial sites (31)

FacilityCityRegionStatus
Bucheon Sejong Hospital Bucheon-si South Korea Recruiting
Gyeongsang National University Changwon Hospital Changwon South Korea Recruiting
Daegu Catholic University Medical Center Daegu South Korea Recruiting
Keimyung University Dongsan Medical Center Daegu South Korea Recruiting
Kyungpook National University Hospital Daegu South Korea Recruiting
Yeungnam University Medical Center Daegu South Korea Withdrawn
Chungnam National University Hospital Daejeon South Korea Recruiting
The Catholic University of Korea, Daejeon ST. Mary's Hospital Daejeon South Korea Recruiting
Gangneung Asan Hospital Gangneung South Korea Recruiting
Chonnam National University Hospital Gwangju South Korea Recruiting
Inje University Ilsan Paik Hospital Ilsan South Korea Recruiting
Gachon University Gil Hospital Incheon South Korea Recruiting
Incheon Sejong Hospital Incheon South Korea Recruiting
Inha University Hospital Incheon South Korea Recruiting
The Catholic University of Korea, Incheon St. Mary's Hospital Incheon South Korea Recruiting
Dong-A Medical Center Pusan South Korea Recruiting
Inje University Pusan Paik Hospital Pusan South Korea Recruiting
Pusan National University Hospital Pusan South Korea Recruiting
Seoul university Bundang hospital Seongnam-si South Korea Recruiting
Asan Medical Center Seoul South Korea Recruiting
Ewha Womans University Mokdong Hospital Seoul South Korea Recruiting
Ewha Womans University Seoul Hospital Seoul South Korea Recruiting
Hanyang University Seoul Hospital Seoul South Korea Recruiting
Konkuk University Medical Center Seoul South Korea Recruiting
Korea University Anam Hospital Seoul South Korea Recruiting
Korea University Guro Hospital Seoul South Korea Recruiting
SNU Boramae Medical Center Seoul South Korea Recruiting
The Catholic Univ. of Korea Eunpyeong St. Mary's hospital Seoul South Korea Recruiting
The Catholic University of Korea, ST. Vincent's Hospital Suwon South Korea Withdrawn
Uijeongbu Eulji Medical Center, Eulji University Uijeongbu-si South Korea Withdrawn
Ulsan University Hospital Ulsan South Korea Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05672836 on ClinicalTrials.gov ↗ ← All trials in South Korea