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Could a diabetes drug help heart failure patients after valve surgery?

NCT ID NCT05672836

Disease control Sponsor: Duk-Woo Park, MD Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 30, 2026 · Updated 2 times

Summary

This study tests whether a drug called enavogliflozin can prevent major heart problems or worsening heart failure in people who have had a heart valve replacement (TAVR) and still have heart failure. About 1,040 participants will receive either the drug or a placebo, in addition to standard care. The main goal is to see if the drug reduces the chance of death, heart attack, stroke, or hospitalization for heart failure over one year.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Enavogliflozin (a drug that helps the kidneys remove sugar from the blood, also used for diabetes)
What this could lead to
If it works, this could provide a new treatment option to reduce heart failure hospitalizations and major heart problems in patients who have had a valve replacement.
What could go wrong
This is a phase 4 trial, so the drug is already approved for diabetes, but its benefit in this specific heart condition is unproven. The trial may show no advantage over placebo, and side effects like dehydration or infections are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 1,040 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Apr 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

19 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

aortic valve stenosis diastolic heart failure heart failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Aortic valve stenosis Heart failure

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    28 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Asan Medical Center

    RECRUITING

    Seoul, South Korea

  • Bucheon Sejong Hospital

    RECRUITING

    Bucheon-si, South Korea

  • Chonnam National University Hospital

    RECRUITING

    Gwangju, South Korea

  • Chungnam National University Hospital

    RECRUITING

    Daejeon, South Korea

  • Daegu Catholic University Medical Center

    RECRUITING

    Daegu, South Korea

  • Dong-A Medical Center

    RECRUITING

    Pusan, South Korea

  • Ewha Womans University Mokdong Hospital

    RECRUITING

    Seoul, South Korea

  • Ewha Womans University Seoul Hospital

    RECRUITING

    Seoul, South Korea

  • Gachon University Gil Hospital

    RECRUITING

    Incheon, South Korea

  • Gangneung Asan Hospital

    RECRUITING

    Gangneung, South Korea

  • Gyeongsang National University Changwon Hospital

    RECRUITING

    Changwon, South Korea

  • Hanyang University Seoul Hospital

    RECRUITING

    Seoul, South Korea

  • Incheon Sejong Hospital

    RECRUITING

    Incheon, South Korea

  • Inha University Hospital

    RECRUITING

    Incheon, South Korea

  • Inje University Ilsan Paik Hospital

    RECRUITING

    Ilsan, South Korea

  • Inje University Pusan Paik Hospital

    RECRUITING

    Pusan, South Korea

  • Keimyung University Dongsan Medical Center

    RECRUITING

    Daegu, South Korea

  • Konkuk University Medical Center

    RECRUITING

    Seoul, South Korea

  • Korea University Anam Hospital

    RECRUITING

    Seoul, South Korea

  • Korea University Guro Hospital

    RECRUITING

    Seoul, South Korea

  • Kyungpook National University Hospital

    RECRUITING

    Daegu, South Korea

  • Pusan National University Hospital

    RECRUITING

    Pusan, South Korea

  • SNU Boramae Medical Center

    RECRUITING

    Seoul, South Korea

  • Seoul university Bundang hospital

    RECRUITING

    Seongnam-si, South Korea

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

    RECRUITING

    Seoul, South Korea

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

    RECRUITING

    Daejeon, South Korea

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

    RECRUITING

    Incheon, South Korea

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

    WITHDRAWN

    Suwon, South Korea

  • Uijeongbu Eulji Medical Center, Eulji University

    WITHDRAWN

    Uijeongbu-si, South Korea

  • Ulsan University Hospital

    RECRUITING

    Ulsan, South Korea

  • Yeungnam University Medical Center

    WITHDRAWN

    Daegu, South Korea

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