MedTrace Logo

CRP Apheresis in Infarct-Related Cardiogenic Shock

NCT07687017 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-07-07

No results posted yet for this study

Summary

Cardiogenic shock complicating acute myocardial infarction remains associated with high short-term mortality despite guideline-directed therapy. Systemic inflammation, particularly elevated C-reactive protein (CRP), may contribute to ongoing myocardial injury and organ dysfunction.

The CRP-SHOCK trial is an investigator-initiated, prospective, randomized, open-label, multicenter pilot study evaluating selective CRP apheresis as an adjunct to standard of care in patients with infarct-related cardiogenic shock. Patients are randomized to receive either standard therapy alone or standard therapy plus selective CRP apheresis using the PentraSorb®-CRP system.

The primary objective is to assess the effect of CRP apheresis on the CLIP score at 66 ± 8 hours after randomization. Secondary objectives include clinical outcomes, inflammatory biomarkers, and safety endpoints.

Conditions

Interventions

DEVICE

Selective C-reactive protein apheresis (PentraSorb®-CRP)

Selective removal of circulating C-reactive protein using the PentraSorb®-CRP adsorber system as an adjunct to guideline-directed standard of care.

OTHER

Standard of care

Guideline-directed medical and interventional treatment for cardiogenic shock complicating acute myocardial infarction.

Sponsors & Collaborators

  • Helios Health Institute GmbH

    collaborator OTHER

  • Heart Center Leipzig at University of Leipzig

    collaborator UNKNOWN

  • Leipzig Heart Science gGmbH

    lead OTHER

Principal Investigators

  • Prof. Dr. med. Holger Thiele Thiele · Heart Center Leipzig at University of Leipzig

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-20
Primary Completion
2027-09-30
Completion
2027-10-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07687017 on ClinicalTrials.gov