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| Name | Class |
|---|---|
| Tanta University | OTHER |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARNI Monotherapy Group: | Placebo Comparator | Patients receiving sacubitril/valsartan without concomitant SGLT2 inhibitor therapy. |
|
| Combination Therapy Group: | Active Comparator | Patients receiving sacubitril/valsartan in combination with an SGLT2 inhibitor (empagliflozin 10 mg daily). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lamiaa Khedr, Ass Prof. | Madina Cardiac Center, KSA | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Madinah Cardiac Center | Madinah | Saudi Arabia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25176015 | Background | 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. | |
| 30132036 |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C000717211 | sacubitril |
| D000068756 | Valsartan |
| C549068 | sacubitril and valsartan sodium hydrate drug combination |
| ID | Term |
|---|---|
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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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).
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|
| 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). |
|
|
| 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. |
| D014633 |
| Valine |
| D000597 | Amino Acids, Branched-Chain |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000601 | Amino Acids, Essential |