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The purpose of this study is to better understand the time course of different biological mechanisms involved in acute decompensated heart failure complicated by cardiogenic shock throughout the evaluation of changes and the relationship among markers of inflammation (IL-6) and markers of increased endothelial permeability (Ang-2) or endothelial glycocalyx perturbation (Syndecan-1 and HS) and throughout a targeted metabolomic approach.
Cardiogenic shock (CS) is a heterogenous syndrome with in-hospital mortality up to 60%, that, unfortunately, has remained stagnant over the time, despite observed improvements with pharmacological and non-pharmacological approach, even though only in terms of haemodynamic stabilization.
While very early mortality in CS is largely related to sudden and severe circulation failure, subsequent death is strongly influenced by activation of neurohumoral and inflammatory response leading to multiorgan failure. Previous studies on CS have almost exclusively been focused on CS following an acute coronary syndrome (ACS). Patients with acutely decompensated heart failure (ADHF) represent a different pathophysiologic phenotype compared with acute coronary syndrome (ACS) patients, which may lead to a differential response to device therapy.
In the face of complex biological phenomena guidelines are incapable of distinguishing the underlying pathophysiological mechanisms and give us input to standardize, whereas there is an unmet need for a personalized medicine.
The evaluation of changes and the relationship among markers of inflammation (IL-6) and markers of increased endothelial permeability (Ang-2) or endothelial glycocalyx perturbation (Syndecan-1 and HS) and an exploratory analysis throughout targeted metabolomics may help us to better understand the time course of different biological mechanisms involved in CS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acute decompensated heart failure | patients admitted with Acute decompensated heart failure Complicated by cardiogenic shock |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ELISA | Diagnostic Test | Blood and derived fluids will be collected from 26 ADHF CS patients admitted to intensive care at Niguarda Hospital and locally stored.Stocked samples will be shipped to the Central Laboratories at Milano Uni and MilaIFC-CNR for the metabolomic and biomarkers analysis,respectively.To evaluate interleukin-6 (marker of systemic inflammation),angiopoietin-2 (marker of endothelial permeability), syndecan-1 and heparan sulfate (markers of endothelial glycocalyx),2 aliquotes of serum samples will be used by IFC CNR.The biomarkers will be assessed through ELISA analytical techniques, based on the interactions inside a microplate between a primary pre-coated antibody and the specific protein contained in serum samples.A secondary antibody, link to a horseradish peroxidase (HRP) detection system, is able to recognize and bind the antigen, and to produce a colorimetric reaction after the addition of enzyme substrate which is proportional to the amount of the target protein bound |
| Measure | Description | Time Frame |
|---|---|---|
| Value of Interleukin 6 (IL-6) | Markers of inflammation. Unit of measure: pg/mL. | 3 years |
| Value of Angiopoietin 2 (Ang-2) | Markers of endothelial permeability. Unit of measure: ng/mL. | 3 years |
| Value of Syndecan-1 | Endothelial glycocalyx perturbation. Unit of measure: ng/mL. | 3 years |
| Value of Heparan sulfate (HS) | Endothelial glycocalyx perturbation: Unit of measure: ug/mL. | 3 years |
| Metabolomics profiling | Exporatory assessment of targeted metabolomics through the quantification of almost 180 molecules, including acylcarnitines, amino acids and biogenic amines, hexoside, sphingolipids and glycerophospholipids. | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
The participant will not be enrolled if ANY of the following criteria will be detected:
Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial
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Patients with acute decompensated heart failure, complicated by cardiogenic shock
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nuccia Morici, MD | Contact | +39026444 | 2643 | nuccia.morici@ospedaleniguarda.it |
| Alice Sacco, MD | Contact | +39026444 | 2567 | alice.sacco@ospedaleniguarda.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda | Recruiting | Milan | 20162 | Italy |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D012770 | Shock, Cardiogenic |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
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Biological samples (blood and derived fluids)
|
| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D012769 | Shock |