RecruitingNCT07379788

ARNI Combined With SGLT2 Inhibitors on Functional Mitral Regurgitation Remodeling

Mitral Remodeling Index: A Novel Composite Measure the Effect of ARNI Alone Versus ARNI Combined With SGLT2 Inhibitors on Functional Mitral Regurgitation Remodeling.

Sponsor

Rehab Werida

Enrollment

180 participants

Start Date

Dec 25, 2025

Study Type

OBSERVATIONAL

Conditions

Heart Failure

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

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria4

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 Criteria6

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.

Interventions

DRUGSacubitril/Valsartan 49 MG-51 MG Oral Tablet [ENTRESTO]

Patients receiving Sacubitril/Valsartan 49 MG-51 MG Oral Tablet without concomitant SGLT2 inhibitor therapy.

DRUGEmpagliflozin10Mg Tab

Combination Therapy Group: Patients receiving Sacubitril/Valsartan 49 MG-51 MG Oral Tablet in combination with an SGLT2 inhibitor (empagliflozin 10 mg daily).