Aortic Valve Stenosis study: Enavogliflozin vs Standard-of-Care
Official title ENAVOgliflozin Outcome Trial in Patients With Severe Aortic Stenosis After Transcatheter Aortic Valve Replacement
ClinicalTrials.gov ID: NCT05672836
What this study is testing
What is Enavogliflozin?
Enavogliflozin is an investigational medicine, taken by mouth once daily, being studied as a potential treatment for aortic valve stenosis.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older
You may be able to join if
- 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...
- absence of periprocedural complications (any type of stroke, life-threatening bleeding, acute coronary artery obstruction requiring intervention...
- Left ventricular ejection fraction (LVEF) ≥40%
- structural heart disease\_Left ventricular hypertrophy (LVH) or Left atrial enlargement A.
You likely can't join if
- Acute decompensated Heart Failure (exacerbation of chronic Heart Failure) requiring intravenous diuretics, vasodilators, inotropic agents, or...
- Currently receiving therapy with an SGLT2 inhibitor within 4 weeks prior to randomization
- 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).
See the full eligibility 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...
- Left ventricular ejection fraction (LVEF) ≥40%
- 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.
- 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\.
- Acute decompensated Heart Failure (exacerbation of chronic Heart Failure) requiring intravenous diuretics, vasodilators, inotropic agents, or mechanical support, or hemodynamic instability following the transcatheter...
- 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).
- 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...
- 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...
- 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...
- 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
- people 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 how well it works evaluation of this trial.
- Screening failed before any treatment 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...
The study team makes the final eligibility decision.
Where it is enrolling
- Bucheon-si, South Korea
- Changwon, South Korea
- Daegu, South Korea
- Daejeon, South Korea
- Gangneung, South Korea
- Gwangju, South Korea
- Ilsan, South Korea
- Incheon, South Korea
- Pusan, South Korea
- Seongnam-si, South Korea
- Seoul, South Korea
- Ulsan, South Korea
Compensation & support
A stipend or payment for your time may be offered.
No amount is published here because ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team, so confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Bucheon-si, South Korea; Changwon, South Korea; Daegu, South Korea; Daejeon, South Korea; Gangneung, South Korea; Gwangju, South Korea and 6 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.