ENAVOgliflozin Outcome Trial in Patients With Severe Aortic Stenosis After Transcatheter Aortic V… (NCT05672836) | Clinical Trial Compass
RecruitingPhase 4
ENAVOgliflozin Outcome Trial in Patients With Severe Aortic Stenosis After Transcatheter Aortic Valve Replacement
South Korea1,040 participantsStarted 2024-12-18
Plain-language 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) among patients who underwent transcatheter aortic valve replacement for severe aortic stenosis and with heart failure with preserved ejection fraction.
Who can participate
Age range19 Years
SexALL
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Inclusion 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).
✓. Left ventricular ejection fraction (LVEF) ≥40%
✓. structural heart disease\_Left ventricular hypertrophy (LVH) or Left atrial enlargement
✓. 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).
Exclusion criteria
✕. 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.
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What they're measuring
1
Time from randomization to first occurrence of a composite of major adverse cardiovascular events* or hospitalization for heart failure