NCT04323371 Cardiogenic Shock Integrated PHenotyping for Event Reduction
| NCT ID | NCT04323371 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Niguarda Hospital |
| Condition | Heart Failure |
| Study Type | OBSERVATIONAL |
| Enrollment | 26 participants |
| Start Date | 2020-06-30 |
| Primary Completion | 2024-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 26 participants in total. It began in 2020-06-30 with a primary completion date of 2024-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04323371 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 74 Years, studying Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04323371 currently recruiting?
Yes, NCT04323371 is actively recruiting participants. Contact the research team at nuccia.morici@ospedaleniguarda.it for enrollment information.
Where is the NCT04323371 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT04323371 clinical trial?
NCT04323371 is sponsored by Niguarda Hospital. The trial plans to enroll 26 participants.
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