drugset / Trial / NCT05672836
ENAVOgliflozin Outcome Trial in Patients With Severe Aortic Stenosis After Transcatheter Aortic Valve Replacement
Phase 4
Recruiting
1040 enrolled
Duk-Woo Park, MD
CardioVascular Research Foundation, Korea · collabDaewoong Pharmaceutical Co. LTD. · collab
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2024-12-18
- Primary completion
- 2028-12
- Completion
- 2029-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Enavogliflozin | Small molecule | 0.3 mg | — |