Myocardial InfarctionNCT06955936
Efferon CT Hemoadsorption for Cardiogenic Shock in Acute Myocardial Infarction
A study testing Efferon CT in people with Myocardial Infarction and Cardiogenic Shock, run by Efferon JSC at 1 site in Russia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Myocardial Infarction, Cardiogenic Shock
- What is being tested?
- Efferon CT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteRussia
- Study dates
- 29 Apr 2025to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
Tomsk NRMC Cardiology Research Institute
Tomsk, 634012
Vyacheslav Ryabov, PhD, MD, +79069481480, rvvt@cardio-tomsk.ru
About this study
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
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.
Read the 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.
- Conditions
- Myocardial Infarction, Cardiogenic Shock
- Being tested
- Efferon CT
- Keywords
- Hemoadsorption, Extracorporeal therapy, Cytokine adsorption, Hemoperfusion
- Medical subject headings
- Myocardial Infarction, Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Efferon CTDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Efferon CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1-7 days
Secondary outcomes (7)
Need for vasopressor support
Need for vasopressors according to the VIS 2020 heart rate scale (Vasoactive inotropic score), measure every 12 hours. VIS is calculated as a weighted sum of all administered vasoactive inotropic agents.
Measured: 0-72 hours
Pulmonary oxygen metabolic function
Measuring PaO2 / FiO2 index every 24 hours
Measured: 1-7 days
SOFA score
The SOFA (Sequential Organ Failure Assessment) index is equal to the sum of six indicators. The higher the score, the greater the insufficiency of the system being assessed. The higher the overall index, the greater the degree of multiorgan dysfunction. Violation of the function of each organ (system) is assessed separately in dynamics against the background of intensive therapy. With a score of no more than 12, multiple organ dysfunctions are assumed, 13-17 points indicate the transition of dysfunction to insufficiency, a score of about 24 indicates a high probability of death. The lower the SOFA index, the less pronounced organ failure and the better the patient's survival prognosis.
Calculation every 24 hours.
Measured: 1-7 days
Duration of ventilation
The time (hours) from the onset of hemoadsorption to the time of disconnection from the ventilator within 7 days or discharge from hospital or transfer from intensive care (if earlier than 7 days).
Measured: 1-7 days
ICU length of stay
Time (days) from the start of hemoadsorption to transfer from the ICU within 7 days or hospital discharge (if earlier than day 7).
Measured: 1-7 days
Hospital length of stay
Time (days) from the start of hemoadsorption to hospital discharge.
Measured: 1-7 days
Incidence and severity of AKI
Frequency of AKI (AKI verified by KDIGO 2012 criteria) and duration (hours) of RRT in patients with AKI
Measured: 1-7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2025
- Study start29 Apr 2025
- Primary completion29 Apr 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Efferon JSC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vyacheslav Ryabov, PhD, MD, Principal investigator, Tomsk NRMC Cardiology Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06955936
- Sponsor's protocol ID
- efferon-ct-2025-01
- Status last verified
- Aug 2026
- First submitted
- 25 Apr 2025
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06955936
- Acronym / sponsor ID
- efferon-ct-2025-01
- Conditions
- Myocardial Infarction, Cardiogenic Shock
- Keywords
- Hemoadsorption, Extracorporeal therapy, Cytokine adsorption, Hemoperfusion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Efferon JSCIndustry (pharma, biotech, devices)
- Study start
- 29 Apr 2025 (actual)
- Primary completion
- 29 Apr 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 2 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: Efferon CTStandard therapy supplemented with a single session of hemoadsorption using Efferon CT. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- Broken-heart syndrome (takotsubo cardiomyopathy)
- Postcardiotomy cardiogenic shock
- Acute myocardial infarction within the last 4 weeks
- Myocarditis
- Cardiac trauma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Efferon CTEfferon 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). | Device | Basic therapy + Efferon CT |
Primary outcome
Time to Resolution of Cardiogenic Shock (Days)
Time frame: 1-7 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
7 secondary outcomes
Need for vasopressor support
Time frame: 0-72 hours
Pulmonary oxygen metabolic function
Time frame: 1-7 days
SOFA score
Time frame: 1-7 days
Duration of ventilation
Time frame: 1-7 days
ICU length of stay
Time frame: 1-7 days
Hospital length of stay
Time frame: 1-7 days
Incidence and severity of AKI
Time frame: 1-7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vyacheslav Ryabov, PhD, MD principal investigator
Tomsk NRMC Cardiology Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Efferon CT in people with Myocardial Infarction and Cardiogenic Shock, run by Efferon JSC at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexandr Shelehov-Kravchenko, PhD, MD (+79636564765, alexandr.shelehov@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Resolution of Cardiogenic Shock (Days) (time frame: 1-7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.