Integrated biomarker phenotyping to reduce complications from cardiogenic shock

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational cohort study of adults with acute decompensated heart failure complicated by cardiogenic shock, focused on the early time course of biological changes. Investigators will collect serial blood samples during initial hospitalization to measure inflammatory markers (IL-6), endothelial permeability markers (Angiopoietin-2), glycocalyx perturbation markers (Syndecan-1 and heparan sulfate), and perform targeted metabolomic profiling. All biomarker assays use established laboratory methods such as ELISA and mass-spectrometry–based metabolomics. The goal is to map relationships among these pathways to identify distinct biological phenotypes that may explain variable outcomes and suggest personalized approaches to management.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.
* Eligible patients shouldn't have contraindications to heart replacement therapy (HRT).

Exclusion Criteria:

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

Where it's running

• Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
  Milan, Italy Recruiting

Study contacts

• Study coordinator: Nuccia Morici, MD
• Email: nuccia.morici@ospedaleniguarda.it
• Phone: +39026444

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.