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

ConditionsAortic Valve StenosisHeart Failure
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age19+
SponsorDuk-Woo Park, MD

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Left ventricular ejection fraction (LVEF) ≥40%

Disqualifiers

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%).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Enavogliflozin

    Drug

    0.3 mg 1 tablet once daily

  • Standard-of-Care

    Drug

    Standard-of-Care medical therapy plus Enavogliflozin matching placebo

Treatment groups

1,040 Participants
are divided into 2 treatment groups
Group A: Enavogliflozin GroupExperimental treatment 1 intervention
Group B: placebo as add-on to standard of care treatment groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame
12 months

Secondary outcomes

1

Event rate of death from any cause

Time frame
12 months
2

Event rate of nonfatal myocardial infarction

Time frame
12 months
3

Event rate of nonfatal stroke

Time frame
12 months
4

Event rate of hospitalization for heart failure

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Duk-Woo Park, MD

Lead sponsor

Asan Medical Center

Sponsor institution

CardioVascular Research Foundation, Korea

Collaborator

Daewoong Pharmaceutical Co. LTD.

Collaborator

Source ClinicalTrials.gov
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