Scientists probe hidden signals in heart failure shock
NCT ID NCT04323371
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at 26 people with severe heart failure who are in cardiogenic shock, a life-threatening condition where the heart can't pump enough blood. Researchers will measure specific markers in the blood related to inflammation and blood vessel health. The goal is to better understand what happens in the body during this crisis, which could help improve future care.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this study could help doctors better understand the biological processes behind cardiogenic shock, potentially leading to more targeted treatments in the future.
- What could go wrong
- This is a very small, early observational study with only 26 participants. It is not testing a treatment, so it will not directly help patients. Results may not apply to all heart failure patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 26 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2020
- Expected to finish
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Mar 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients with acute decompensated heart failure, complicated by cardiogenic shock
- Ages
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18 to 74 years
- Sex
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Anyone
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
RECRUITINGMilan, 20162, Italy
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