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Recruiting NCT07379788

ARNI Combined With SGLT2 Inhibitors on Functional Mitral Regurgitation Remodeling

Trial Parameters

Condition Heart Failure
Sponsor Rehab Werida
Study Type OBSERVATIONAL
Phase N/A
Enrollment 180
Sex ALL
Min Age 18 Years
Max Age 80 Years
Start Date 2025-12-25
Completion 2026-02-28
Interventions
Sacubitril/Valsartan 49 MG-51 MG Oral Tablet [ENTRESTO]Empagliflozin10Mg Tab

Brief Summary

This study aimed to compare the effects of ARNI monotherapy versus combined ARNI and SGLT2 inhibitor therapy on Mitral Remodeling Index (MRIx) and Functional mitral regurgitation (FMR) remodeling in patients with heart failure with reduced ejection fraction (HFrEF).

Eligibility Criteria

Inclusion Criteria: * age ≥18 years; * left ventricular ejection fraction (LVEF) \<50%; * Presence of functional mitral regurgitation (mild, moderate, or severe) on transthoracic echocardiography; and * stable sinus rhythm or controlled atrial fibrillation. Exclusion Criteria: * primary (degenerative or rheumatic) mitral valve disease, * prior mitral valve surgery or transcatheter intervention, * acute decompensated heart failure within four weeks, * significant primary valvular disease other than FMR, * severe renal impairment (estimated glomerular filtration rate \<30 mL/min/1.73 m²), * inadequate echocardiographic image quality.

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