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Cardiogenic Shock Integrated PHenotyping for Event Reduction

ConditionHeart Failure
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-74
SponsorNiguarda Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 and < 75, men and women;

1) Systolic blood pressure (SBP) < 90mmHg or mean arterial pressure (MAP) < 60 mmHg, after an appropriate fluid challenge if there is no sign of overt fluid overload; OR 2) need of vasoactive agents to maintain SBP > 90 mmHg or MAP > 60 mmHg.

Reduced ejection fraction (left ventricle systolic function ≤35%).

Moreover, eligible patients have to fit at least ONE of the following criteria/items of overt hypoperfusion: altered state of consciousness; sweaty and cold skin; mixed venous oxygen saturation < 60%; arterial lactates > 2 mmol/L; oliguria < 0.5 ml/Kg/h for at least 6 hours.

Disqualifiers

Cardiogenic shock symptoms beyond 6 hours.

Septic shock with evident septic focus.

Cardiogenic shock due to acute myocardial infarction.

Cardiogenic shock due to acute myocarditis.

Trial population

Patients with acute decompensated heart failure, complicated by cardiogenic shock

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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

Treatment groups

26 Participants
are divided into 1 treatment group
Group A: Acute decompensated heart failure1 intervention

Trial outcomes

Primary outcomes

1

Value of Interleukin 6 (IL-6)

Markers of inflammation. Unit of measure: pg/mL.

Time frame
3 years
2

Value of Angiopoietin 2 (Ang-2)

Markers of endothelial permeability. Unit of measure: ng/mL.

Time frame
3 years
3

Value of Syndecan-1

Endothelial glycocalyx perturbation. Unit of measure: ng/mL.

Time frame
3 years
4

Value of Heparan sulfate (HS)

Endothelial glycocalyx perturbation: Unit of measure: ug/mL.

Time frame
3 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Niguarda Hospital

Lead sponsor

Source ClinicalTrials.gov
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