Danish Cardiogenic Shock Trial

Summary

Cardiogenic shock a serious complication of a heart attack (myocardial infarction). Despite rapid invasive treatment, circulatory support using positive inotropes and mechanical support with intra-aortic balloon counterpulsation (IABP), and evaluation of several new treatments during the last decade, the mortality in patients with cardiogenic shock still exceeds 50%. An alternative to current management is restoration of the volume of blood pumped by the heart (cardiac output) using a ventricular assist device. In the acute setting this is difficult but can be done using the Impella device which is a catheter-based, axial flow pump that pumps blood directly from the left ventricle into the circulation thereby restoring blood flow to the failing organs. In 2012 a more powerful Impella has been introduced that is able to deliver 3.5l/min (approximately 75% of a normal cardiac output). The hypothesis of the current study is to reduce mortality and morbidity of patients with cardiogenic shock using the Impella CP. The study will be carried out as a randomized multicenter study where eligible patients will be randomized to receive conventional circulatory support or support with the Impella device and inotropic support if needed. A total of 360 patients are planned to be enrolled, and the primary endpoint will be death.

Conditions

• Cardiogenic Shock Acute
• Acute Myocardial Infarction

Interventions

DEVICE

Conventional circulatory support

Control group treated with conventional circulatory support and observed in intensive care unit for a minimum of 48 hrs.

DEVICE

Impella CP

Control group treated with Impella CP for a minimum of 48 hrs.

Sponsors & Collaborators

• Aarhus University Hospital Skejby

  collaborator OTHER

• Hannover Medical School

  collaborator OTHER

• University Hospital, Bonn

  collaborator OTHER

• Jena University Hospital

  collaborator OTHER

• University Hospital Dresden

  collaborator OTHER

• Heinrich-Heine University, Duesseldorf

  collaborator OTHER

• Universitätsklinikum Hamburg-Eppendorf

  collaborator OTHER

• Charite University, Berlin, Germany

  collaborator OTHER

• Royal Brompton & Harefield NHS Foundation Trust

  collaborator OTHER

• Wuerzburg University Hospital

  collaborator OTHER

• Rigshospitalet, Denmark

  collaborator OTHER

• Odense University Hospital

  lead OTHER

Principal Investigators

• Jacob E Moller, MD · Department of Cardiology, Odense University Hospital, Odense

• Anders Junker, MD · Department of Cardiology, Odense University Hospital

• Christian Hassager, MD · Department of Cardiology, Copenhagen University Hospital Gentofte

• Andreas Shaefer, MD · Hannover Medical School

• Nikos Werner, MD · University Hospital Trier

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-12-31

Primary Completion

2023-07-31

Completion

2024-04-30

Countries

• Denmark
• Germany
• United Kingdom

Study Locations