NCT05672836

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

A Randomized, Double-Blind, Placebo-controlled Trial to Evaluate Efficacy and Safety of a Novel Sodium-Glucose Cotransporter 2 Inhibitor, Enavogliflozin Compared to Placebo on Reducing Major Cardiovascular Events or Worsening Heart Failure in Patients With Severe Aortic Stenosis Who Underwent Transcatheter Aortic Valve Replacement (TAVR) and With Heart Failure With Preserved Ejection Fraction (HFpEF)

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,040 (estimated)
• Sponsor: Duk-Woo Park, MD · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Aortic Valve Stenosis
• Heart Failure

Interventions

Type	Name	Description
DRUG	Enavogliflozin	0.3 mg 1 tablet once daily
DRUG	Standard-of-Care	Standard-of-Care medical therapy plus Enavogliflozin matching placebo

Timeline

• Start date: 2024-12-18
• Primary completion: 2026-12-01
• Completion: 2027-04-01
• First posted: 2023-01-05
• Last updated: 2025-12-15

Locations

31 sites across 1 country: South Korea