NCT05672836

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

Name: Clinical Trial NCT05672836
Creator: Duk-Woo Park, MD
Keywords: Aortic Valve Stenosis, Enavogliflozin, Phase 4, drug, clinical trial, South Korea

A Randomized, Open-Label, Parallel Group Trial to Evaluate the Effect of Angiotensin Receptor-Neprilysin Inhibitor (ARNI; Sacubitril/Valsartan) Compared With Standard-of-Care on Reduction of Adverse Clinical Events and Cardiac Reverse Remodeling in Patients Who Underwent Transcatheter Aortic Valve Implantation

Duk-Woo Park, MD·Phase 4·ClinicalTrials.gov·drugNot yet recruiting

View on ClinicalTrials.gov →

Study focus

Disease/Condition: Aortic Valve Stenosis
Drug/Device/Intervention: Enavogliflozin
Study type: Interventional
Intervention type: drug

Sponsor & location

Primary sponsor: Duk-Woo Park, MD
Funder: Asan Medical Center
Location: Seoul, South Korea

Timeline & enrollment

Phase: Phase 4
Start date: Jun 01, 2023
End date: Apr 01, 2026
Enrollment: 1040 participants

Primary outcome

Time from randomization to first occurrence of a composite of major adverse cardiovascular events* or hospitalization for heart failure

Summary

The goal of this trial is to determine whether the use of a novel SGLT2 inhibitor(Sodium-glucose Cotransporter-2), Enavogliflozin is safe and effective for the improvement of adverse clinical outcomes and the reversal of adverse cardiac remodelling among patients who had undergone TAVR as compared with the standard-of-care therapy.

ICD-10 classifications

Aortic (valve) stenosisAortic (valve) stenosis with insufficiencyCongenital stenosis of aortic valveStenosis of aortaRheumatic aortic stenosis

Data source

Registry: ClinicalTrials.gov
Trial ID: NCT05672836
Type: Non-Device Trial

About this record

Access comprehensive clinical trial information for NCT05672836 through Pure Global AI's free database. This Phase 4 trial is sponsored by Duk-Woo Park, MD and is currently Not yet recruiting. The study focuses on Aortic Valve Stenosis. Target enrollment is 1040 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.