Cardiogenic Shock Integrated PHenotyping for Event Reduction
Recruiting now
Conditions studied: Heart Failure
In brief
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.
Key facts
- Study ID
- NCT04323371
- Run by
- Niguarda Hospital
- People needed
- 26
- Starts
- 2020-06-30
- Expected to finish
- 2028-03-01
- Last updated by the study team
- 2026-04-16
Who can join
Age: 18 and older, up to 74. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
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
Where it is running
- Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda — Milan, Italy (enrolling)
Full record on ClinicalTrials.gov
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