Efferon CT Hemoadsorption for Cardiogenic Shock in Acute Myocardial Infarction

Efferon

Status: Enrolling

Conditions: Myocardial Infarction; Cardiogenic Shock

Treatments: Device: Efferon CT

Study type: Interventional

Funder types: Industry

Identifiers

NCT06955936

efferon-ct-2025-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

60 participants in 2 patient groups

Baseline therapy

No Intervention group

Description:

Standard therapy (according to the clinical guidelines "Cardiogenic Shock (2025)" issued by the "Russian Federation of Anaesthesiologists and Reanimatologists").

Basic therapy + Efferon CT

Experimental group

Description:

Standard therapy supplemented with a single session of hemoadsorption using Efferon CT.

Treatment:

Device: Efferon CT