← Back to all trials
Recruiting
NCT05672836
ENAVOgliflozin Outcome Trial in Patients With Severe Aortic Stenosis After Transcatheter Aortic Valve Replacement
Conditions: Aortic Valve Stenosis, Heart Failure
Sex: All
Ages: 19 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 1040
Sponsor: Duk-Woo Park, MD
Location: Bucheon Sejong Hospital Bucheon-si
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.
Eligibility Criteria
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 \
Source: ClinicalTrials.gov (NCT05672836). StuddyBuddy aggregates publicly available trial information.