Health Trials

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

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

Treatments tested in this trial

  • Enavogliflozin
  • Standard-of-Care

Treatment groups

1,040 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Duk-Woo Park, MD

Lead sponsor

Asan Medical Center

Sponsor institution

CardioVascular Research Foundation, Korea

Collaborator

Daewoong Pharmaceutical Co. LTD.

Collaborator

Source ClinicalTrials.gov