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Failing heart negative remodeling alterations might provide electrical heterogeneity and cardiac remodeling, thus potentially contributing to the occurrence of ventricular arrhythmia and subsequent sudden cardiac death (SCD). In this study we have prospectively investigated whether sodium glucose transporte-2 inhibitors (SGLT2i) could modulate serum markers of heart failure (ultra sensitive Troponin , B type Natriuretic Peptide (BNP), C reactive protein (CRP), the heart rate (HR) and serum catecholamines in patients with type 2 diabetes mellitus (T2DM), and be used as predictors for the occurrence of malignant ventricular arrhythmias (VTAs) in patients who had received an Implantable Cardioverter Defibrillator (ICD) for primary prevention. In these T2DM patients with ICD we investigated the functionality of devices, the appropriate and inappropriate shocks, and the hospitalizations for heart failure and the cardiac deaths.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Heart failure patients with T2DM and treated with ICD under SGLT2i therapy. | These patients with T2DM and stable heart failure were previously treated with ICD, and received a SGLT2i therapy. These patients were named SGLT2i-users. | ||
| Heart failure patients with T2DM and treated with ICD and without SGLT2i therapy. | Heart failure patients with T2DM and treated with ICD that did not receive the SGLT2i therapy. These patients were named Non-SGLT2i users. |
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| Measure | Description | Time Frame |
|---|---|---|
| cardiac deaths | authors will report cardiac deaths by hospital discarge schedules, visits, telephonic interviews, and deaths registry. | 12 months |
| Heart failure hospitalization | authors will report heart failure hospitalization by hospital discarge schedules, visits, telephonic interviews. | 12 months |
| ICDs' intervention | authors will report ICDs' intervention by hospital discarge schedules, visits, telephonic interviews, and telemetric devices interrogations. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| arrhythmic burden | authors will report arrhythmic burden by hospital discarge schedules, visits, telephonic interviews, egg hollering, and telemetric devices interrogations. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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heart failure patients with reduced LVEF (LVEF <35%) and affected by T2DM, previously treated with ICD and indication to receive SGLT2i therapy.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Raffaele Marfella | Naples | Italy | 80128 | Italy |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
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| D008659 |
| Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |