ARNI Combined With SGLT2 Inhibitors on Functional Mitral Regurgitation Remodeling

Rehab Werida

Status: Completed

Conditions: Heart Failure

Treatments: Drug: Sacubitril/Valsartan 49 MG-51 MG Oral Tablet [ENTRESTO]; Drug: Empagliflozin10Mg Tab

Study type: Interventional

Funder types: Other

Identifiers

NCT07379788

ARNI, SGLT2 Inhibitors & MRI

Details and patient eligibility

About

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).

Full description

This was a study conducted at Madinah Cardiac Center (MCC), Saudi Arabia, a tertiary referral center with a high-volume heart-failure unit and advanced echocardiographic services. Consecutive patients with chronic heart failure with reduced ejection fraction (HFrEF) and functional mitral regurgitation (FMR) were enrolled between [January 2025] and [December 2025].

Eligible patients were on sacubitril/valsartan (ARNI), either as monotherapy or in combination with a sodium-glucose cotransporter-2 (SGLT2) inhibitor, according to contemporary heart failure guidelines and treating physician discretion.

The study protocol conformed to the principles of the Declaration of Helsinki and was approved by the local institutional ethics committee; Madinah Cardiac Center before the beginning of the study.

• Treatment Groups

Patients were stratified into two groups based on pharmacological therapy:

1. ARNI Monotherapy Group: Patients receiving sacubitril/valsartan without concomitant SGLT2 inhibitor therapy.
2. Combination Therapy Group: Patients receiving sacubitril/valsartan in combination with an SGLT2 inhibitor (empagliflozin 10 mg daily).

Enrollment: 180 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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180 participants in 2 patient groups, including a placebo group

ARNI Monotherapy Group:

Placebo Comparator group

Description:

Patients receiving sacubitril/valsartan without concomitant SGLT2 inhibitor therapy.

Treatment:

Drug: Sacubitril/Valsartan 49 MG-51 MG Oral Tablet [ENTRESTO]

Combination Therapy Group:

Active Comparator group

Description:

Patients receiving sacubitril/valsartan in combination with an SGLT2 inhibitor (empagliflozin 10 mg daily).

Treatment:

Drug: Empagliflozin10Mg Tab