NCT04323371

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
22mo left

Started Jun 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress76%
Jun 2020Mar 2028

First Submitted

Initial submission to the registry

March 11, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 26, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

June 30, 2020

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Expected
Last Updated

April 16, 2026

Status Verified

April 1, 2026

Enrollment Period

3.7 years

First QC Date

March 11, 2020

Last Update Submit

April 13, 2026

Conditions

Heart Failure

Keywords

heart failurecardiogenic shockendothelial glycocalyxAngiopoietin (Ang)-2Metabolomics

Outcome Measures

Primary Outcomes (5)

  • 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

Study Arms (1)

Acute decompensated heart failure

patients admitted with Acute decompensated heart failure Complicated by cardiogenic shock

Diagnostic Test: ELISA

Interventions

ELISADIAGNOSTIC_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

Acute decompensated heart failure

Eligibility Criteria

Age18 Years - 74 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with acute decompensated heart failure, complicated by cardiogenic shock

You may qualify if:

  • Age ≥ 18 and \< 75, men and women;
  • \) 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.
  • Eligible patients shouldn't have contraindications to heart replacement therapy (HRT).

You may not qualify if:

  • The participant will not be enrolled if ANY of the following criteria will be detected:
  • 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.
  • Cardiogenic shock due to pulmonary thromboembolism.
  • Reiterating major arrhythmias: VT or VF or AF, with ventricular rate \> 160 bpm.
  • Severe aortic valve disease.
  • Obstructive hypertrophic cardiomyopathy or constrictive pericarditis or severe heart failure due to congenital heart disease
  • Severe peripheral vascular disease that contraindicates mechanical support insertion.
  • Cardiogenic shock secondary to either cardiac or non-cardiac surgery.
  • Comorbidities with ominous prognosis (life expectancy \< 1 year).
  • Estimated glomerular filtration rate severely impaired before enrolment (eGFR\<30 ml/min/1.73 m2) or severe chronic obstructive pulmonary disease (COPD) or liver cirrhosis.
  • Pregnant, lactating or subjects planning pregnancy during the course of the trial.
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

Milan, 20162, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Biological samples (blood and derived fluids)

MeSH Terms

Conditions

Heart FailureShock, Cardiogenic

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesMyocardial InfarctionMyocardial IschemiaVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisShock

Central Study Contacts

Nuccia Morici, MD

CONTACT

+39026444nuccia.morici@ospedaleniguarda.it

Alice Sacco, MD

CONTACT

+39026444alice.sacco@ospedaleniguarda.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2020

First Posted

March 26, 2020

Study Start

June 30, 2020

Primary Completion

March 1, 2024

Study Completion (Estimated)

March 1, 2028

Last Updated

April 16, 2026

Record last verified: 2026-04

Locations

IT(1)