Mitral Remodeling Index: A Novel Composite Measure the Effect of ARNI Alone Versus ARNI Combined With SGLT2 Inhibitors on Functional Mitral Regurgitation Remodeling.
| Registry | NCT07379788 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: double, treatment |
| Enrollment | 180 (Actual) |
| Sponsor | Rehab Werida (Other); collaborators: Tanta University |
| Conditions | Heart Failure |
| Interventions | Sacubitril/Valsartan 49 MG-51 MG Oral Tablet [ENTRESTO], Empagliflozin10Mg Tab (Drug) |
| Dates | start 2025-01-01, primary completion 2026-02-28, completion 2026-03-01, first posted 2026-01-30, last updated 2026-06-02 |
| Locations | 1 site in Saudi Arabia |
Related Papers Related Patents Related Grants Related Experts
All trials for Heart Failure All trials of Sacubitril/Valsartan 49 MG-51 MG Oral Tablet [ENTRESTO] All trials of Empagliflozin10Mg Tab
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).
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).
| Arm | Type | Interventions | Description |
|---|---|---|---|
| ARNI Monotherapy Group: | Placebo comparator | Drug: Sacubitril/Valsartan 49 MG-51 MG Oral Tablet [ENTRESTO] | Patients receiving sacubitril/valsartan without concomitant SGLT2 inhibitor therapy. |
| Combination Therapy Group: | Active comparator | Drug: Empagliflozin10Mg Tab | Patients receiving sacubitril/valsartan in combination with an SGLT2 inhibitor (empagliflozin 10 mg daily). |
Sex: All, ages: 18 Years to 80 Years
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Madinah Cardiac Center | Madinah | Saudi Arabia |