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The study is aimed to evaluate the improvement of the left ventricular volumes and of the left ventricular ejection fraction in a population of ICD patients with heart failure and left ventricle systolic dysfunction undergoing therapy with Sacubitril/Valsartan (according to current Guidelines), during a 6-month follow-up.
Consecutive, unselected patients with heart failure and left ventricle systolic dysfunction, carrying a single-chamber or a bicameral implantable cardioverter defibrillator (ICD) for primary prevention of sudden death, undergoing therapy with Sacubitril/Valsartan (according to current Guidelines) will be enrolled in the study. A two-dimensional echocardiogram with evaluation of left ventricular end-diastolic volume, left ventricular end-systolic volume, and left ventricular ejection fraction will be performed, according to standard clinical practice, at the beginning of the observation, and at a 6-month follow-up. The improvement of the left ventricle volumes and of the left ventricular ejection fraction will be evaluated.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| two-dimensional echocardiogram | Diagnostic Test | two-dimensional echocardiogram with evaluation of left ventricle volumes and of left ventricular ejection fraction |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in left ventricular ejection fraction | Difference between the ejection fraction observed at baseline and that observed at 6 months of follow-up | at enrollment and at 6 months of follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in left ventricle volumes | Difference between the left ventricle volumes measured at baseline and those measured at 6 months of follow-up | at enrollment and at 6 months of follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with heart failure, left ventricular systolic dysfunction, carrying a single-chamber or a bicameral implantable cardioverter defibrillator implanted for primary prevention of sudden death, and undergoing therapy with Sacubitril/Valsartan according to current Guidelines
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| "Card. G. Panico" Hospital | Recruiting | Tricase | Lecce | 73039 | Italy |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Federico Guerra | Recruiting | Ancona | Italy |
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| Policlinico S.Orsola-Malpighi | Recruiting | Bologna | 40138 | Italy |
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| AO Pugliese-Ciaccio | Recruiting | Catanzaro | 88100 | Italy |
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| Monaldi Hospital | Recruiting | Naples | Italy |
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| AOU "Maggiore della Carità " | Recruiting | Novara | 28100 | Italy |
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