ARNI Combined With SGLT2 Inhibitors on Functional Mitral Regurgitation Remodeling

NCT07379788 | Completed

• 1 other identifier: ARNI, SGLT2 Inhibitors & MRI
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

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).

Conditions

Heart Failure

Keywords

Left atrial volume index (LAVI); Mitral Remodeling Index (MRIx); left ventricular ejection fraction (LVEF); functional mitral regurgitation (FMR)

Outcome Measures

Primary Outcomes (4)

• LVEF %

  Change in left ventricular ejection fraction percent

  6 months

• Left Atrial Volume index (LAVI)

  Change Left Atrial Volume index (LAVI)

  6 months

• Mitral Remodeling Index

  Change in Mitral Remodeling Index

  6 months

• Peak GLS number

  Change in Peak Global Longitudinal Strain

  6 months

Study Arms (2)

ARNI Monotherapy Group:

Patients receiving sacubitril/valsartan without concomitant SGLT2 inhibitor therapy.

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

Combination Therapy Group:

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

Drug: Empagliflozin10Mg Tab

Interventions

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

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

Also known as: Entresto

ARNI Monotherapy Group:

Empagliflozin10Mg Tab DRUG

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

Also known as: Empagliflozin10Mg plus Sacubitril/Valsartan 49 MG-51 MG Oral Tablet

Combination Therapy Group:

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

• Treatment Groups Patients were stratified into two groups based on pharmacological therapy: 1. ARNI Monotherapy Group: Patients receiving Sacubitril/Valsartan 49 MG-51 MG Oral Tablet without concomitant SGLT2 inhibitor therapy. 2. Combination Therapy Group: Patients receiving Sacubitril/Valsartan 49 MG-51 MG Oral Tablet sacubitril/valsartan in combination with an SGLT2 inhibitor (empagliflozin 10 mg daily). Sacubitril/valsartan was initiated and up titrated to the maximally tolerated dose according to guideline recommendations (13). SGLT2 inhibitors were prescribed at standard approved doses. Background heart failure therapy, including beta-blockers and mineralocorticoid receptor antagonists, was maintained whenever clinically feasible.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rehab Werida: lead
• Tanta University: collaborator
• Madinah Cardiac Center in Madinah, KSA.: collaborator

Study Sites (1)

Madinah Cardiac Center

Madinah, Saudi Arabia

Location

Related Publications (2)

• McMurray JJ, Packer M, Desai AS, Gong J, Lefkowitz MP, Rizkala AR, Rouleau JL, Shi VC, Solomon SD, Swedberg K, Zile MR; PARADIGM-HF Investigators and Committees. Angiotensin-neprilysin inhibition versus enalapril in heart failure. N Engl J Med. 2014 Sep 11;371(11):993-1004. doi: 10.1056/NEJMoa1409077. Epub 2014 Aug 30.

  PMID: 25176015 BACKGROUND

• Verma S, McMurray JJV. SGLT2 inhibitors and mechanisms of cardiovascular benefit: a state-of-the-art review. Diabetologia. 2018 Oct;61(10):2108-2117. doi: 10.1007/s00125-018-4670-7. Epub 2018 Aug 22.

  PMID: 30132036 BACKGROUND

MeSH Terms

Conditions

Heart Failure

Interventions

sacubitril; Valsartan; sacubitril and valsartan sodium hydrate drug combination

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential

Study Officials

• Lamiaa Khedr, Ass Prof.

  Madina Cardiac Center, KSA

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 23, 2026
• First Posted: January 30, 2026
• Study Start: December 25, 2025
• Primary Completion: February 28, 2026
• Study Completion: March 1, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)