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

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

Plain Language Summary

Simplified for easier understanding

This study evaluates whether combining an ARNI medication (sacubitril/valsartan — a drug that helps the heart pump better) with SGLT2 inhibitors (a class of diabetes/heart failure drugs) can improve a heart problem called functional mitral regurgitation, where the mitral heart valve leaks because the heart muscle is weak. **You may be eligible if...** - You are 18 or older - Your heart's pumping function (ejection fraction) is below 50% - You have been diagnosed with functional mitral regurgitation (mild, moderate, or severe) on an echocardiogram (heart ultrasound) - Your heart rhythm is in normal sinus rhythm or controlled atrial fibrillation **You may NOT be eligible if...** - Your mitral valve leaks due to structural problems (degenerative or rheumatic disease), rather than heart muscle weakness - You have previously had mitral valve surgery or a catheter-based valve procedure - You had a heart failure episode requiring hospitalization in the last 4 weeks - You have severe kidney disease - Your echocardiogram images are of insufficient quality Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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).


Locations(1)

Madinah Cardiac Center

Madinah, Saudi Arabia

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NCT07379788


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