Efferon CT Hemoadsorption for Cardiogenic Shock in Acute Myocardial Infarction

NCT06955936 | Recruiting

• 1 other identifier: efferon-ct-2025-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Infarction; Cardiogenic Shock

Keywords

Hemoadsorption; Extracorporeal therapy; Cytokine adsorption; Hemoperfusion

Outcome Measures

Primary Outcomes (1)

• Time to Resolution of Cardiogenic Shock (Days)

  Time from randomization to sustained hemodynamic stabilization, defined as: Mean arterial pressure (MAP) ≥65 mmHg and Heart rate ≤110 bpm and Cessation of vasopressors/inotropes (e.g., norepinephrine, dopamine) and mechanical circulatory support (MCS). Persistence of all criteria for ≥4 consecutive hours

  1-7 days

Secondary Outcomes (7)

• Need for vasopressor support

  0-72 hours

• Pulmonary oxygen metabolic function

  1-7 days

• SOFA score

  1-7 days

• Duration of ventilation

  1-7 days

• ICU length of stay

  1-7 days

Study Arms (2)

Baseline therapy

NO INTERVENTION

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

Basic therapy + Efferon CT

EXPERIMENTAL

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

Device: Efferon CT

Interventions

Efferon CT DEVICE

Efferon CT (JSC Efferon, Moscow, RF) is a device for extracorporeal blood purification by direct hemoadsorption. Detoxification is carried out by sorption of cytokines and other products of endogenous intoxication with a molecular size of up to 55 kDa. The therapy will be performed once no later than 4 hours after the diagnosis of cardiogenic shock. The duration of hemoadsorption is from 4 to 12 hours. The rate of hemoadsorption is from 80 to 150 ml/min. Anticoagulation is systemic (heparin or sodium citrate).

Basic therapy + Efferon CT

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Efferon JSC: lead

Study Sites (1)

Tomsk NRMC Cardiology Research Institute

Tomsk, 634012, Russia

RECRUITING

MeSH Terms

Conditions

Myocardial Infarction; Shock, Cardiogenic

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Study Officials

• Vyacheslav Ryabov, PhD, MD

  Tomsk NRMC Cardiology Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandr Shelehov-Kravchenko, PhD, MD

CONTACT

+79636564765; alexandr.shelehov@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: April 25, 2025
• First Posted: May 2, 2025
• Study Start: April 29, 2025
• Primary Completion (Estimated): April 29, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: June 5, 2025

Record last verified: 2025-04

Locations

RU (1)