Heart Failure
Conditions
Keywords
Left atrial volume index (LAVI), Mitral Remodeling Index (MRIx), left ventricular ejection fraction (LVEF), functional mitral regurgitation (FMR)
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).
Detailed 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).
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.
Combination Therapy Group: Patients receiving Sacubitril/Valsartan 49 MG-51 MG Oral Tablet in combination with an SGLT2 inhibitor (empagliflozin 10 mg daily).
Sponsors
Rehab Werida
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
This was a randomized controlled study included 180 HFrEF patients (LVEF \<50%) with FMR, recruited from a tertiary cardiac referral center, who were randomized to receive either sacubitril/valsartan alone (n=90) or in combination with empagliflozin (n=90).
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| LVEF % | 6 months | Change in left ventricular ejection fraction percent |
| Left Atrial Volume index (LAVI) | 6 months | Change Left Atrial Volume index (LAVI) |
| Mitral Remodeling Index | 6 months | Change in Mitral Remodeling Index |
| Peak GLS number | 6 months | Change in Peak Global Longitudinal Strain |
Countries
Saudi Arabia
Contacts
STUDY_DIRECTORLamiaa Khedr, Ass Prof.
Madina Cardiac Center, KSA
Outcome results
None listed