Clinical trial NCT06955936: Efferon CT Hemoadsorption for Cardiogenic Shock in Acute Myocardial Infarction
Official title: An Open Randomized Study on the Efficacy and Safety of Hemoadsorption With Efferon CT in Patients With Cardiogenic Shock Complicating Acute Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myocardial Infarction
Cardiogenic Shock
Keywords: Hemoadsorption
Extracorporeal therapy
Cytokine adsorption
Hemoperfusion
Lead sponsor: Efferon JSC
Sponsor class: INDUSTRY
First posted: 2025-05-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Allocation of patients into groups will be done by stratified 1:1 randomisation.

Patients will be stratified into 2 groups based on the severity of cardiogenic shock according to the SCAI classification (stages B and C).
Primary purpose: TREATMENT

Brief summary: Cardiogenic shock is the most severe manifestation of acute heart failure and remains the leading cause of death in patients hospitalised with acute myocardial infarction.

Cardiogenic shock is a well-known and potent trigger of the immune response, ischemia/reperfusion organ damage, hemolysis and release of free hemoglobin. The activation of immune cells leads to the release of cytokines and inflammatory mediators such as IL-6, IL-8, activated complement and others. As a result of myocardial ischaemia and reperfusion injury, a multiorgan dysfunction syndrome may develop.

The Efferon CT hemoadsorption device effectively removes cytokines and other pro-inflammatory molecules (≤55 kDa). This study evaluates whether this blood-filtering therapy can prevent organ failure in acute myocardial infarction patients with cardiogenic shock by eliminating inflammation-inducing mediators.

Detailed description: Cardiogenic shock (CS) is a state of acute critical tissue hypoperfusion caused by impaired myocardial contractility. It is one of the most serious complications of acute coronary syndrome (ACS), particularly acute myocardial infarction (AMI). Cardiogenic shock develops in approximately 30-40% of ACS patients, with a one-year mortality rate of 50-60%.

Despite advances in modern cardiology-including widespread use of timely revascularization, vasopressors, inotropic agents, and mechanical circulatory support-CS-related mortality remains unacceptably high. Efferent therapy, which modulates the homeostasis of biological fluids (e.g., blood) through physical and chemical methods (filtration, apheresis, sorption), represents a promising approach.

Recent studies on the hemoadsorbent CytoSorb in acute cardiac pathology demonstrated reductions in inflammatory markers (IL-6, lactate), improved hemodynamic stability, and lower 30-day ICU mortality (52% vs. 80% SOFA-predicted). These findings highlight the potential of cytokine adsorption to mitigate systemic inflammation in CS.

The Efferon CT hemoadsorption device, which effectively removes cytokines and other pro-inflammatory molecules (≤55 kDa), may improve outcomes by alleviating CS symptoms and preventing multiple organ dysfunction.

Eligibility criteria: Inclusion Criteria:

* Not more than 4 hours after diagnosis Cardiogenic shock complicating acute myocardial infarction
* Stages B - C of cardiogenic shock according to SCAI
* Patient condition allows treatment with Efferon® CT device for at least 4 hours
* SOFA score 12 or less

Exclusion Criteria:

* Broken-heart syndrome (takotsubo cardiomyopathy)
* Postcardiotomy cardiogenic shock
* Acute myocardial infarction within the last 4 weeks
* Myocarditis
* Cardiac trauma
* Charlson comorbidity index greater than 9 points
* Chronic kidney disease, stage 5 D (requiring continuous hemodialysis)
* Acute pulmonary embolism
* Acute cerebral circulatory collapse
* Transfusion reaction
* Patients on immunosuppressive therapy for cancer and autoimmune diseases
* Pregnancy
* Any other clinical condition of the patient that in the opinion of the investigator precludes inclusion in this study

Primary outcomes:
measure: Time to Resolution of Cardiogenic Shock (Days)
timeFrame: 1-7 days
Secondary outcomes:
measure: Need for vasopressor support
timeFrame: 0-72 hours
measure: Pulmonary oxygen metabolic function
timeFrame: 1-7 days
measure: SOFA score
timeFrame: 1-7 days
measure: Duration of ventilation
timeFrame: 1-7 days
measure: ICU length of stay
timeFrame: 1-7 days
measure: Hospital length of stay
timeFrame: 1-7 days
measure: Incidence and severity of AKI
timeFrame: 1-7 days
Other outcomes:
Locations:
city: Tomsk
country: Russian Federation
facility: Tomsk NRMC Cardiology Research Institute
Study officials:
affiliation: Tomsk NRMC Cardiology Research Institute
name: Vyacheslav Ryabov, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References: