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Aortic Valve StenosisPhase 4ENAVO-TAVRNCT05672836

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

A Phase 4 study testing Enavogliflozin and Standard-of-Care in people with Aortic Valve Stenosis and Heart Failure, run by Duk-Woo Park, MD at 31 sites in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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)… Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Aortic Valve Stenosis, Heart Failure
What is being tested?
Enavogliflozin and Standard-of-Care
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,040 participants
Where
31 sitesSouth Korea
Study dates
18 Dec 2024to Apr 2029
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • correct positioning of a single prosthetic heart valve into the proper anatomical location AND
  • 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
  • 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
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  • Left ventricular ejection fraction (LVEF) ≥40%
  • structural heart disease_Left ventricular hypertrophy (LVH) or Left atrial enlargement
  • Left ventricular hypertrophy (LVH) with septal thickness or posterior wall thickness ≥ 1.1 cm or
  • 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.
  • 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

Who cannot join

  • 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.
  • 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.
  • Known allergy, hypersensitivity, or previous intolerance to an SGLT2 inhibitors.
  • HF with reduced ejection fraction (LVEF <40%).
  • Type 1 diabetes mellitus or diabetes ketoacidosis.
  • Chronic cystitis and/or recurrent urinary tract infection (≥2 times within 1 year).
Show all 25Show fewer
  • Stroke or transient ischemic attack within 12 weeks prior to enrollment.
  • Symptomatic persistent hypotension and/or a systolic blood pressure (SBP) < 95 mm Hg at screening or at randomization.
  • SBP ≥180 mmHg irrespective of treatment or SBP ≥160 mmHg with at least ≥3 antihypertensive drugs at screening or randomization.
  • 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.
  • 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.
  • 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.
  • 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.
  • Current or suspicious malignancy or history of malignancy within 5 years
  • Uncontrolled anaemia or haemoglobin <9g/dl
  • Uncontrolled hypothyroidism or arrhythmia or tachycardia
  • Current ongoing alcoholic or drug addict
  • Subjects with non-cardiac co-morbidities with life expectancy less than 12 months
  • Planned major high-risk operation after transcatheter aortic valve replacement (TAVR)
  • Women of childbearing age who have not reached a consensus on the use of highly effective contraception. Pregnancy or breastfeeding.
  • 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.

Trial locations and contacts

31 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jeong-youn Bae, Project manager contact

82230107259

cvcrc10@amc.seoul.kr

31 sites in 1 country

South Korea31 sites, 28 recruiting

  • Bucheon Sejong Hospital

    Bucheon-si

    Young-jin Choi, MD

    Young-jin Choi, MD

    Recruiting

  • Gyeongsang National University Changwon Hospital

    Changwon

    Jae-seok Bae, MD

    Jae-seok Bae, MD

    Recruiting

  • Daegu Catholic University Medical Center

    Daegu

    Jin-bae Lee, MD

    Jin-bae Lee, MD

    Recruiting

  • Keimyung University Dongsan Medical Center

    Daegu

    Chul-hyun Lee, MD

    Chul-hyun Lee, MD

    Recruiting

  • Kyungpook National University Hospital

    Daegu

    Dong-heon Yang, MD

    Dong-heon Yang, MD

    Recruiting

  • Yeungnam University Medical Center

    Daegu

    Withdrawn

  • Chungnam National University Hospital

    Daejeon

    Jin-Ok Jeong, MD

    Jin-Ok Jeong, MD

    Recruiting

  • The Catholic University of Korea, Daejeon ST. Mary's Hospital

    Daejeon

    Man-won Park, MD

    Man-won Park, MD

    Recruiting

  • Gangneung Asan Hospital

    Gangneung

    Han-bit Park, MD

    Han-bit Park, MD

    Recruiting

  • Chonnam National University Hospital

    Gwangju

    Ju-han Kim, MD

    Ju-han Kim, MD

    Recruiting

  • Inje University Ilsan Paik Hospital

    Ilsan

    Seong-wook Kwon, MD

    Seong-wook Kwon, MD

    Recruiting

  • Gachon University Gil Hospital

    Incheon

    Woong-cheol Kang, MD

    Woong-cheol Kang, MD

    Recruiting

  • Incheon Sejong Hospital

    Incheon

    Rak-kyoung Choi, MD

    Rak-kyoung Choi, MD

    Recruiting

  • Inha University Hospital

    Incheon

    Sang-don Park, MD

    Sang-don Park, MD

    Recruiting

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

    Incheon

    Ik-joon Choi, MD

    Ik-joon Choi, MD

    Recruiting

  • Dong-A Medical Center

    Pusan

    Yong-rak Cho, MD

    Yong-rak Cho, MD

    Recruiting

  • Inje University Pusan Paik Hospital

    Pusan

    Tae-hyun Yang, MD

    Tae-hyun Yang, MD

    Recruiting

  • Pusan National University Hospital

    Pusan

    Jung-Hyun Choi, MD

    Jung-Hyun Choi, MD

    Recruiting

  • Seoul university Bundang hospital

    Seongnam-si

    In-ho Chae, MD

    In-ho Chae, MD

    Recruiting

  • Asan Medical Center

    Seoul

    Duk-woo Park, MD

    Duk-woo Park, MD

    Recruiting

  • Ewha Womans University Mokdong Hospital

    Seoul

    In-sook Kang, MD

    In-sook Kang, MD

    Recruiting

  • Ewha Womans University Seoul Hospital

    Seoul

    Sang-hoon Shin, MD

    Sang-hoon Shin, MD

    Recruiting

  • Hanyang University Seoul Hospital

    Seoul

    Hyungdon Kook, MD

    Hyungdon Kook, MD

    Recruiting

  • Konkuk University Medical Center

    Seoul

    Bum-seong Kim, MD

    Bum-seong Kim, MD

    Recruiting

  • Korea University Anam Hospital

    Seoul

    Chul-woong Yoo, MD

    Chul-woong Yoo, MD

    Recruiting

  • Korea University Guro Hospital

    Seoul

    Cheol-ung Choi, MD

    Cheol-ung Choi, MD

    Recruiting

  • SNU Boramae Medical Center

    Seoul

    Woo-young Jeong, MD

    Woo-young Jeong, MD

    Recruiting

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

    Seoul

    Jeong-hoon Lee, MD

    Jeong-hoon Lee, MD

    Recruiting

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

    Suwon

    Withdrawn

  • Uijeongbu Eulji Medical Center, Eulji University

    Uijeongbu-si

    Withdrawn

  • Ulsan University Hospital

    Ulsan

    Kyoung-min Park, MD

    Kyoung-min Park, MD

    Recruiting

Other trials in South Korea

About this study

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)

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.

Being tested
Enavogliflozin, Standard-of-Care
Keywords
Transcatheter Aortic Valve Implantation, heart failure with preserved ejection fraction, Sodium-glucose cotransporter-2 inhibitor, transcatheter aortic valve replacement
Medical subject headings
Aortic Valve Stenosis, Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EnavogliflozinDrug

    0.3 mg 1 tablet once daily

  • Standard-of-CareDrug

    Also called Standard-of-Care medical therapy

    Standard-of-Care medical therapy plus Enavogliflozin matching placebo

Study groups in NCT05672836
Study groupRoleWhat they receive
Enavogliflozin GroupExperimental0.3 mg 1 tablet once daily
Receives: Drug: Enavogliflozin
placebo as add-on to standard of care treatment groupPlacebo comparatorPlacebo matching enavogliflozin
Receives: Drug: Standard-of-Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time from randomization to first occurrence of a composite of major adverse cardiovascular events* or hospitalization for heart failure

    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.

    Measured: 12 months

Secondary outcomes (10)

  1. Event rate of death from any cause

    Measured: 12 months

  2. Event rate of nonfatal myocardial infarction

    Measured: 12 months

  3. Event rate of nonfatal stroke

    Measured: 12 months

  4. Event rate of hospitalization for heart failure

    Measured: 12 months

  5. Event rate of Composite renal endpoint

    Composite renal endpoint, defined as time to first occurrence of (1) chronic dialysis; (2) renal transplantation; (3) sustained reduction of ≥40% in estimated glomerular filtration rate (GFR); or (4) sustained estimated GFR <15 mL/min/1.73 m2 for patients with baseline estimated GFR ≥30 mL/min/1.73 m2.

    Measured: 12 months

  6. Event rate of Rehospitalization for any reason

    Measured: 12 months

  7. Changes in measures of cardiac volume and function assessed by serial echocardiography

    left ventricular ejection fraction(LVEF), LV end-diastolic volume index (LVEDVI), LV end-systolic volume index (LVESVI), left atrial volume index (LAVI), and the ratio of early transmitral Doppler velocity/early diastolic annular velocity (E/e')

    Measured: 12 months

  8. Changes in New York Heart Association (NYHA) functional class and the Kansas City Cardiomyopathy Questionnaire (KCCQ) summary score

    New York Heart Association (NYHA) Functional Classification on a scale from I to IV, with higher scores indicating severe symptoms and physical limitations associated with heart failure.

    the Kansas City Cardiomyopathy Questionnaire (KCCQ)on a scale from 0 to 100, with higher scores indicating fewer symptoms and physical limitations associated with heart failure.

    Measured: 12 months

  9. Serial change in NT-proBNP

    N-terminal (NT)-pro hormone BNP (NT-proBNP)

    Measured: 12 months

  10. Event rate of the safety events

    The safety events are defined as;

    • Serious adverse events
    • Adverse events leading to treatment discontinuation
    • Adverse events of special interest(AESI)
    • Hypoglycemia, genitourinary infections, hepatic injury, decreased renal function, ketoacidosis, events leading to lower limb amputation
    • AESIs leading to treatment discontinuation

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2023
  2. Study start18 Dec 2024
  3. Primary completionDec 2028 (estimated)
  4. Study completionApr 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,040 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05672836
Sponsor's protocol ID
AMCCV2023-01
Acronym
ENAVO-TAVR
Status last verified
Jun 2026
First submitted
1 Jan 2023
Last updated
29 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Enavogliflozin and Standard-of-Care in people with Aortic Valve Stenosis and Heart Failure, run by Duk-Woo Park, MD at 31 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jeong-youn Bae, Project manager (82230107259, cvcrc10@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time from randomization to first occurrence of a composite of major adverse cardiovascular events* or hospitalization for heart failure (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05672836.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.

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