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Incretin therapy and sodium-glucose- transporter2 inhibitors (SGLT2i) are a treatment for type 2 diabetes (T2DM) affected by heart failure (HF) and treated with cardiac resynchromization therapy (CRT). In this study the investigators will recruit T2DM patients affected by HF with depressed ejection fraction and treated by CRT. These patients will randomly be treated by incretin v/s SGLT2i vs combined therapy with incretin+SGLT2i (and added to conventional hypoglicemic drugs). In these patients investigators will report at follow up CRT-d responders rate, mortality, and hospital admission for HF worsening. Combined therapy with incretin and SGLT2i may reduce hospital admissions for HF in T2DM v/s incretin and/or SGLT2i therapy (added to conventional hypoglicemic drugs).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| incretin arm | Active Comparator | T2DM with HF treated by CRTd participants will be assigned prospectively to an intervention (incretin therapy plus conventional hypoglycemic drug therapy) according to study protocol to evaluate the effect of the drug on cardiac deaths, all cause deaths, and hospital admission for heart failure. |
|
| conventional hypoglycemic drug arm | Placebo Comparator | T2DM with HF treated by CRTd participants will be assigned prospectively to SGLT2i therapy (plus conventional hypoglycemic drug therapy) according to study protocol to evaluate the effect of the drug on cardiac deaths, all cause deaths, and hospital admission for heart failure. |
|
| Incretin added to SGLT2i | Active Comparator | T2DM with HF treated by CRTd participants will be assigned prospectively to SGLT2i added to incretin therapy (plus conventional hypoglycemic drug therapy) according to study protocol to evaluate the effect of the drug on cardiac deaths, all cause deaths, and hospital admission for heart failure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Incretin Effect | Drug | The patients will receive incretins therapy. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| all cause mortality, and cardiac cause mortality. | 12 months | |
| CRT responders | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| hospital admissions for HF | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Raffaele Marfella | Naples | Italy | 80128 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30348145 | Derived | Sardu C, Paolisso P, Sacra C, Santamaria M, de Lucia C, Ruocco A, Mauro C, Paolisso G, Rizzo MR, Barbieri M, Marfella R. Cardiac resynchronization therapy with a defibrillator (CRTd) in failing heart patients with type 2 diabetes mellitus and treated by glucagon-like peptide 1 receptor agonists (GLP-1 RA) therapy vs. conventional hypoglycemic drugs: arrhythmic burden, hospitalizations for heart failure, and CRTd responders rate. Cardiovasc Diabetol. 2018 Oct 22;17(1):137. doi: 10.1186/s12933-018-0778-9. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D054795 | Incretins |
| D000077203 | Sodium-Glucose Transporter 2 Inhibitors |
| ID | Term |
|---|---|
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
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| Cardiac Resynchronization therapy defibrillator device |
| Device |
The patients will receive a Cardiac Resynchronization therapy defibrillator device |
|
| SGLT-2 inhibitor | Drug | The patients will receive SGLT2i therapy. |
|
| D004700 | Endocrine System Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D020164 | Chemical Actions and Uses |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D007004 | Hypoglycemic Agents |