NCT04323371Recruiting
Cardiogenic Shock Integrated PHenotyping for Event Reduction
Source: ClinicalTrials.gov · Last updated 16 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 26 (estimated)
- First submitted
- 11 Mar 2020
- Start date
- 30 Jun 2020
- Primary completion date
- 1 Mar 2024
- Lead sponsor
- Niguarda Hospital
- Diseases
- Heart failure
- NCT number
- NCT04323371
What you commit to
- Study type: Observational
- Planned participants: 26
- From 30 Jun 2020 to the primary completion date, 1 Mar 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Cardiogenic shock due to acute myocardial infarction.
- 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.
- 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
Lab values
- 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.
Other
- 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 myocarditis.
- Comorbidities with ominous prognosis (life expectancy \< 1 year).
Who the study is looking for
- 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).
Age in the registry: 18 years to 74 years · Sex: All
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.