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| Name | Class |
|---|---|
| Ministry of Health, Russian Federation | OTHER_GOV |
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Patients enrolled into the study will be randomly allocated either to Empagliflozin group or control group. In the Empagliflozin group patients will be receiving standard care + Empagliflozin 10 mg o.d., in the control group patients will be receiving standard care without sodium glucose contransporter 2 (SGLT2) inhibitors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Empagliflozin | Experimental | Patients will receive standard care for Heart Failure and Diabetes Mellitus + Empagliflozin 10mg once daily |
|
| Control | Active Comparator | Patients will receive standard care for Heart Failure and Diabetes Mellitus with no SGLT-2 inhibitors |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Empagliflozin | Drug | 10 mg tablet |
| |
| Standard care |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 6-minute walking distance (6MWD) | Difference in distance walked during 6-minute walking test (6MWT) between 24 weeks after baseline and at baseline | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in left ventricular mass index (LVMI) | Difference in LVMI assessed by echocardiography between 24 weeks after baseline and at baseline | 24 weeks |
| Change in left atrial volume index (LAVI) |
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Inclusion Criteria:
Males and females aged 45 to 80 years at screening
Diagnosis of type-2 diabetes mellitus with stable glucose-lowering background therapy for at least 12 weeks
HbA1c ≥ 6,5% and ≤ 10% at screening
Diagnosis of HFpEF which includes:
Signed and dated informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anton Borisov, MD | National Medical Research Center for Cardiology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Medical Research Center for Cardiology | Moscow | 121552 | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40346546 | Derived | Ovchinnikov A, Potekhina A, Filatova A, Svirida O, Zherebchikova K, Ageev F, Belyavskiy E. Effects of empagliflozin on functional capacity, LV filling pressure, and cardiac reserves in patients with type 2 diabetes mellitus and heart failure with preserved ejection fraction: a randomized controlled open-label trial. Cardiovasc Diabetol. 2025 May 9;24(1):196. doi: 10.1186/s12933-025-02756-y. |
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| Other |
Standard care with no SGLT-2 inhibitors |
|
Difference in LAVI assessed by echocardiography between 24 weeks after baseline and at baseline
| 24 weeks |
| Change in left atrial stiffness | Difference in left atrial stiffness assessed as a ratio of mitral E/e' ratio to left atrial strain s between 24 weeks after baseline and at baseline | 24 weeks |
| Change estimated pulmonary artery systolic pressure (PASP) | Difference in PASP assessed by echocardiography both at rest and during diastolic stress test (DST) between 24 weeks after baseline and at baseline | 24 weeks |
| Change in average e' velocity | Difference in average e' velocity assessed by echocardiography both at rest and during diastolic stress test (DST) between 24 weeks after baseline and at baseline | 24 weeks |
| Change in average E/e' ratio | Difference in average E/e' ratio assessed by echocardiography both at rest and during diastolic stress between 24 weeks after baseline and at baseline | 24 weeks |
| Change in N-terminal pro b-type natriuretic peptide (NT-proBNP) | Difference in NT-proBNP plasma levels between 24 weeks after baseline and at baseline | 24 weeks |
| Change in Cyclic guanosine monophosphate (cGMP) | Difference in cGMP plasma levels between 24 weeks after baseline and at baseline | 24 weeks |
| Change in Endothelin 1 (ET-1) | Difference in ET-1 plasma levels between 24 weeks after baseline and at baseline | 24 weeks |
| Change in Growth/differentiation factor 15 (GDF-15) | Difference in GDF-15 plasma levels between 24 weeks after baseline and at baseline | 24 weeks |
| Change in ST2 | Difference in ST2 plasma levels between 24 weeks after baseline and at baseline | 24 weeks |
| Change in Galectin-3 | Difference in Galectin-3 plasma levels between 24 weeks after baseline and at baseline | 24 weeks |
| Change in carboxyterminal propeptide of type I collagen (PICP) | Difference in PICP plasma levels between 24 weeks after baseline and at baseline | 24 weeks |
| Change in Human Pentraxin 3 (PTX3) | Difference in PTX3 plasma levels between 24 weeks after baseline and at baseline | 24 weeks |
| Change in high-sensitivity C-reactive protein (hsCRP) | Difference in hsCRP plasma levels between 24 weeks after baseline and at baseline | 24 weeks |
| Change in Interleukin-6 (IL-6) | Difference in IL-6 plasma levels between 24 weeks after baseline and at baseline | 24 weeks |
| Change of New York Heart Association (NYHA) functional classification | Difference in NYHA class between 24 weeks after baseline and at baseline | 24 weeks |
| Change in Minnesota Living With Heart Failure Questionnaire (MLHFQ) score | Difference in MLHFQ score between 24 weeks after baseline and at baseline. The questionnaire is comprised of 21 important physical, emotional and socioeconomic ways heart failure can adversely affect a patient's life. After receiving brief standardized instructions, the patient marks a 0 (zero) to 5 scale to indicate how much each itemized adverse of heart failure has prevented the patient from living as he or she wanted to live during the past 4 weeks. The questionnaire is simply scored by summation of all 21 responses. Score ranges from 0 (best quality of life) to 105 (worst quality of life). | 24 weeks |
| ID | Term |
|---|---|
| D054144 | Heart Failure, Diastolic |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C570240 | empagliflozin |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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