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Sodium-glucose cotransporter 2 inhibitors (SGLT2i) reduce CVD events, including incident HF. SGLT2 is a glucose transport protein in the kidneys. Inhibition of this protein results in glucosuria and lower serum blood sugar. The SGLT2i medications were initially approved to treat type 2 diabetes (T2D). In 2015, Zinman et al. published the first large randomized clinical trial (RCT) demonstrating a lower composite CVD outcome in adults with T2D treated with empagliflozin compared to placebo (HR 0.85, 95% CI 0.74-0.99). In the specific case of empagliflozin, the hazard ratio was 0.75 (95% CI 0.65-0.86) for HFrEF 8 and 0.79 (95% CI 0.69-0.90) for HFpEF using a treatment dose of 10mg daily.
The purpose of this placebo-controlled, double-blinded, randomized pilot study is to investigate the effect of empagliflozin on left atrial (LA) function in 80 patients who are at risk for heart failure. Participants will be randomized 1:1 to either intake of a 10mg empagliflozin oral tablet or a matching placebo once daily.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental |
| |
| Placebo group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| empagliflozin | Drug | intake of a 10mg empagliflozin oral tablet At visit 1, after randomization, participants will be provided with bottles containing enough study pills for 3 months duration at 1 tablet daily. Participants will start the study drug on the morning following Visit 1. At the 3 month follow up visit, participants will be provided with enough study pills to complete the remaining 6 months of the study. |
| Measure | Description | Time Frame |
|---|---|---|
| change in LA function | LA function will be quantified by assessing LA reservoir, conduit, and contractile strain with 2DE at baseline and 9 months. | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| change in left ventricular ejection fraction | 9 months | |
| change in global longitudinal strain | 9 months | |
| change in mass (indexed to body surface area) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Julie Dicken, RN | Contact | dicke022@umn.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jeremy Van't Hof, MD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Recruiting | Minneapolis | Minnesota | 55414 | United States |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| C570240 | empagliflozin |
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placebo-controlled, double-blinded, randomized pilot study
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|
| Placebo tablet | Drug | intake a placebo oral tablet At visit 1, after randomization, participants will be provided with bottles containing enough study pills for 3 months duration at 1 tablet daily. Participants will start the study drug on the morning following Visit 1. At the 3 month follow up visit, participants will be provided with enough study pills to complete the remaining 6 months of the study. |
|
| 9 months |
| change in E/e' ratio | 9 months |
| change in plasma protein levels: DLK-1 (protein delta homolog 1) | 9 months |
| change in plasma protein levels: GDF15 (growth differentiating factor 15) | 9 months |
| change in plasma protein levels: Spondin-1 | 9 months |
| change in plasma protein levels: IGBPF-7 | 9 months |
| change in plasma protein levels: THBS-2 (thrombospondin 2) | 9 months |
| change in plasma protein levels: IGFBP-1 (insulin-like binding factor protein 1) | 9 months |
| change in plasma protein levels: FABP-4 (fatty acid-binding protein 4) | 9 months |
| change in plasma protein levels: CCL16 (C-C motif chemokine 16) | 9 months |
| change in cardiovascular disease biomarker C-reactive protein (CRP) | 3 months and 9 months |
| change in cardiovascular disease biomarker Troponin | 3 months and 9 months |
| change in cardiovascular disease biomarker NT-proBNP | 3 months and 9 months |
| changes in blood pressure ration | 1, 3 and 9 months |