Actively Recruiting

Age: 18Years - 74Years
All Genders
NCT04323371

Cardiogenic Shock Integrated PHenotyping for Event Reduction

Led by Niguarda Hospital · Updated on 2026-04-16

26

Participants Needed

1

Research Sites

400 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Cardiogenic Shock Integrated PHenotyping for Event Reduction

Who Can Participate

Age: 18Years - 74Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to less than 75 years, men and women
  • Systolic blood pressure below 90 mmHg or mean arterial pressure below 60 mmHg after fluid challenge without fluid overload, or need for vasoactive agents to maintain blood pressure above these values
  • Reduced left ventricle systolic function with ejection fraction 35% or less
  • At least one sign of overt hypoperfusion such as altered consciousness, cold and sweaty skin, mixed venous oxygen saturation below 60%, arterial lactates above 2 mmol/L, or urine output less than 0.5 ml/kg/hour for at least 6 hours
  • No contraindications to heart replacement therapy
Not Eligible

You will not qualify if you...

  • Cardiogenic shock symptoms lasting more than 6 hours
  • Septic shock with clear infection source
  • Cardiogenic shock caused by acute myocardial infarction
  • Cardiogenic shock caused by acute myocarditis
  • Cardiogenic shock caused by pulmonary thromboembolism
  • Recurrent major arrhythmias including ventricular tachycardia, ventricular fibrillation, or atrial fibrillation with ventricular rate above 160 bpm
  • Severe aortic valve disease
  • Obstructive hypertrophic cardiomyopathy, constrictive pericarditis, or severe heart failure from congenital heart disease
  • Severe peripheral vascular disease preventing mechanical support insertion
  • Cardiogenic shock secondary to cardiac or non-cardiac surgery
  • Comorbidities with life expectancy less than one year
  • Severe kidney impairment (eGFR below 30 ml/min/1.73 m2), severe chronic obstructive pulmonary disease, or liver cirrhosis
  • Pregnancy, breastfeeding, or planning pregnancy during the study
  • Any other significant disease or condition that may put the participant at risk or affect study results as judged by the investigator

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

Milan, Italy, 20162

Actively Recruiting

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Research Team

N

Nuccia Morici, MD

CONTACT

A

Alice Sacco, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Cardiogenic Shock Integrated PHenotyping for Event Reduction | DecenTrialz