ENAVOgliflozin Outcome Trial in Patients With Severe Aortic Stenosis After Transcatheter Aortic Valve Replacement - Trial NCT05672836

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

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.

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NCT05672836

Phase 4

Not yet recruiting

drug

Trial Details

ClinicalTrials.gov • NCT05672836

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

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

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) stenosis

Aortic (valve) stenosis with insufficiency

Congenital stenosis of aortic valve

Stenosis of aorta

Rheumatic aortic stenosis

Data Source

Registry

ClinicalTrials.gov

Trial ID

NCT05672836

Type

Non-Device Trial