Danish Cardiogenic Shock Trial

NCT01633502 | Completed DMC

• 1 other identifier: DanShock-01
• Study Type: interventional
• Target: 360
• Locations: 3 countries
• Sites: 13

Brief 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

Outcome Measures

Primary Outcomes (1)

• Death

  Death from all causes

  up to 6 months

Secondary Outcomes (3)

• MACE

  minimum follow-up 6 months

• Composite saftey

  up to 6 months

• Days alive out of hospital

  up tp 6 months

Other Outcomes (8)

• Hemodynamics

  up to 7 days

• Hemodynamics

  up to 7 days

• Hemodynamics

  up to 7 days

Study Arms (2)

Conventional circulatory support

PLACEBO COMPARATOR

Patients randomized to conventional circulatory support.

Device: Conventional circulatory support

Impella

ACTIVE COMPARATOR

Patients randomized to Impella CP

Device: Impella CP

Interventions

Conventional circulatory support DEVICE

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

Also known as: Conventional circulatory support will be employed according to enrolling sites usual management.

Conventional circulatory support

Impella CP DEVICE

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

Also known as: Impella CP, Abiomed

Impella

Eligibility Criteria

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

You may qualify if:

• ST segment elevation myocardial infarction of less than 36 hours' duration, confirmed by new onset ST-segment elevation, or emergency angiography demonstrating acute occlusion of coronary artery, and
• Cardiogenic shock of less than 24 hours' duration, confirmed by:
• peripheral signs of tissue hypoperfusion (arterial blood lactate ≥2.5mmol/l and/or SvO2 \<55% with a normal PaO2) and
• systolic blood pressure less than 100mmHg and/or need for vasopressor therapy (dopamine/ norepinephrine or epinephrine), and
• Left ventricular ejection fraction of less than 45% visually estimated or by wall motion score index \>1,6.

You may not qualify if:

• Other causes of shock (hypovolemia, hemorrhage, sepsis, pulmonary embolism or anaphylaxis).
• Shock due to mechanical complication to myocardial infarction (papillary muscle rupture, rupture of the ventricular septum or rupture of free wall).
• Severe aorta valve regurgitation/stenosis.
• Predominant right ventricular failure.
• Out of hospital cardiac arrest with persistent Glasgow coma scale \<8 after return of spontaneous circulation.
• Shock duration\>24 hours.
• Known heparin intolerance.
• Already established mechanical circulatory support
• Do not resuscitate wish.

Sponsors & Collaborators

• Odense University Hospital: lead
• Aarhus University Hospital Skejby: collaborator
• Hannover Medical School: collaborator
• University Hospital, Bonn: collaborator
• Jena University Hospital: collaborator
• University Hospital Dresden: collaborator
• Heinrich-Heine University, Duesseldorf: collaborator
• Universitätsklinikum Hamburg-Eppendorf: collaborator
• Charite University, Berlin, Germany: collaborator
• Royal Brompton & Harefield NHS Foundation Trust: collaborator
• Wuerzburg University Hospital: collaborator
• Rigshospitalet, Denmark: collaborator

Study Sites (13)

Aarhus University Hospital Skejby

Aarhus, 8200, Denmark

Location

Copenhagen University Hospital Rigshospitalet

Copenhagen, 2100, Denmark

Location

Odense University Hospital

Odense, DK-5000, Denmark

Location

Charite Berlin

Berlin, Germany

Location

University Hospital Bonn

Bonn, Germany

Location

Dresden University Hospital

Dresden, Germany

Location

Düsseldorf University Hospital

Düsseldorf, Germany

Location

UKE Hamburg

Hamburg, Germany

Location

Hannover Medical School

Hanover, Germany

Location

Jena University Hospital

Jena, Germany

Location

Brüderkrankenhaus Trier

Trier, Germany

Location

University Hospital Würzburg

Würzburg, Germany

Location

NHs Harefield Hospital

London, United Kingdom

Location

Related Publications (10)

• Moller JE, Gerke O; DanGer Shock Investigators. Danish-German cardiogenic shock trial-DanGer shock: Trial design update. Am Heart J. 2023 Jan;255:90-93. doi: 10.1016/j.ahj.2022.10.078. Epub 2022 Oct 19.

  PMID: 36272450 BACKGROUND

• Udesen NJ, Moller JE, Lindholm MG, Eiskjaer H, Schafer A, Werner N, Holmvang L, Terkelsen CJ, Jensen LO, Junker A, Schmidt H, Wachtell K, Thiele H, Engstrom T, Hassager C; DanGer Shock investigators. Rationale and design of DanGer shock: Danish-German cardiogenic shock trial. Am Heart J. 2019 Aug;214:60-68. doi: 10.1016/j.ahj.2019.04.019. Epub 2019 May 6.

  PMID: 31176289 BACKGROUND

• Moller JE, Engstrom T, Jensen LO, Eiskjaer H, Mangner N, Polzin A, Schulze PC, Skurk C, Nordbeck P, Clemmensen P, Panoulas V, Zimmer S, Schafer A, Werner N, Frydland M, Holmvang L, Kjaergaard J, Sorensen R, Lonborg J, Lindholm MG, Udesen NLJ, Junker A, Schmidt H, Terkelsen CJ, Christensen S, Christiansen EH, Linke A, Woitek FJ, Westenfeld R, Mobius-Winkler S, Wachtell K, Ravn HB, Lassen JF, Boesgaard S, Gerke O, Hassager C; DanGer Shock Investigators. Microaxial Flow Pump or Standard Care in Infarct-Related Cardiogenic Shock. N Engl J Med. 2024 Apr 18;390(15):1382-1393. doi: 10.1056/NEJMoa2312572. Epub 2024 Apr 7.

  PMID: 38587239 RESULT

• Jensen LO, Beske RP, Eiskjaer H, Mangner N, Polzin A, Schulze PC, Skurk C, Nordbeck P, Clemmensen P, Panoulas V, Zimmer S, Schafer A, Werner N, Holmvang L, Wachtell K, Engstom T, Udesen NLJ, Schmidt H, Junker A, Terkelsen CJ, Christensen S, Linke A, Moller JE, Hassager C; DanGer Shock Investigators. Delay From First Symptoms in Patients Presenting With STEMI and Cardiogenic Shock: Insights From the DanGer Shock Trial. Circ Cardiovasc Interv. 2026 Jan 12:e015718. doi: 10.1161/CIRCINTERVENTIONS.125.015718. Online ahead of print.

  PMID: 41521915 DERIVED

• Mangner N, Beske RP, Hassager C, Jensen LO, Eiskjaer H, Linke A, Polzin A, Schulze PC, Skurk C, Nordbeck P, Clemmensen P, Panoulas V, Zimmer S, Schafer A, Werner N, Engstrom T, Holmvang L, Lonborg JT, Udesen NLJ, Schmidt H, Junker A, Terkelsen CJ, Schrage B, Woitek FJ, Moller JE; DanGer Shock Investigators. Sex-Specific Microaxial Flow Pump Use and Outcomes in Infarct-Related Cardiogenic Shock in the DanGer Shock Trial. J Am Coll Cardiol. 2025 Oct 17:S0735-1097(25)07782-4. doi: 10.1016/j.jacc.2025.09.019. Online ahead of print.

  PMID: 41222528 DERIVED

• Mikkelsen AD, Beske RP, Jensen LO, Eiskjaer H, Mangner N, Polzin A, Schulze C, Skurk C, Nordbeck P, Schrage B, Panoulas V, Zimmer S, Schafer A, Engstrom T, Holmvang L, Frydland M, Junker AB, Schmidt H, Udesen NLJ, Wachtell K, Terkelsen CJ, Linke A, Kjaergaard J, Moller JE, Hassager C; DanGer Shock Investigators. Systolic Blood Pressure and Microaxial Flow Pump-Associated Survival in Infarct-Related Cardiogenic Shock: A Post Hoc Analysis of the DanGer Shock Randomized Clinical Trial. JAMA Cardiol. 2025 Nov 1;10(11):1157-1165. doi: 10.1001/jamacardio.2025.3337.

  PMID: 40884241 DERIVED

• Moller JE, Beske RP, Jensen LO, Eiskjaer H, Mangner N, Polzin A, Schulze PC, Skurk C, Nordbeck P, Schrage B, Panoulas V, Zimmer S, Schafer A, Werner N, Holmvang L, Kjaergaard J, Engstom T, Udesen NLJ, Schmidt H, Junker A, Wachtell K, Terkelsen CJ, Christensen S, Linke A, Burkhoff D, Hassager C; DanGer Shock Investigators. Effect of Microaxial Flow Pump on Hemodynamics in STEMI-Related Cardiogenic Shock. J Am Coll Cardiol. 2025 Jul 1;85(25):2456-2468. doi: 10.1016/j.jacc.2025.04.062.

  PMID: 40562510 DERIVED

• Klein A, Beske RP, Hassager C, Jensen LO, Eiskjaer H, Mangner N, Linke A, Polzin A, Schulze PC, Skurk C, Nordbeck P, Clemmensen P, Panoulas V, Zimmer S, Schafer A, Werner N, Engstom T, Holmvang L, Junker A, Schmidt H, Terkelsen CJ, Moller JE; DanGer Shock Investigators. Treating Older Patients in Cardiogenic Shock With a Microaxial Flow Pump: Is it DANGERous? J Am Coll Cardiol. 2025 Feb 18;85(6):595-603. doi: 10.1016/j.jacc.2024.11.003. Epub 2024 Nov 15.

  PMID: 39551167 DERIVED

• Zweck E, Hassager C, Beske RP, Jensen LO, Eiskjaer H, Mangner N, Polzin A, Schulze PC, Skurk C, Nordbeck P, Clemmensen P, Panoulas V, Zimmer S, Schafer A, Kelm M, Engstrom T, Holmvang L, Junker A, Schmidt H, Terkelsen CJ, Linke A, Westenfeld R, Moller JE; DanGer Shock Investigators. Microaxial Flow Pump Use and Renal Outcomes in Infarct-Related Cardiogenic Shock: A Secondary Analysis of the DanGer Shock Trial. Circulation. 2024 Dec 17;150(25):1990-2003. doi: 10.1161/CIRCULATIONAHA.124.072370. Epub 2024 Oct 27.

  PMID: 39462276 DERIVED

• Udesen NLJ, Beske RP, Hassager C, Jensen LO, Eiskjaer H, Mangner N, Polzin A, Schulze PC, Skurk C, Nordbeck P, Clemmensen P, Panoulas V, Zimmer S, Schafer A, Werner N, Frydland M, Holmvang L, Kjaergaard J, Engstom T, Schmidt H, Junker A, Terkelsen CJ, Christensen S, Linke A, Moller JE; DanGer Shock Investigators. Microaxial Flow Pump Hemodynamic and Metabolic Effects in Infarct-Related Cardiogenic Shock: A Substudy of the DanGer Shock Randomized Clinical Trial. JAMA Cardiol. 2025 Jan 1;10(1):9-16. doi: 10.1001/jamacardio.2024.4197.

  PMID: 39462240 DERIVED

Study Officials

• Jacob E Moller, MD

  Department of Cardiology, Odense University Hospital, Odense

  PRINCIPAL INVESTIGATOR

• Anders Junker, MD

  Department of Cardiology, Odense University Hospital

  STUDY CHAIR

• Christian Hassager, MD

  Department of Cardiology, Copenhagen University Hospital Gentofte

  STUDY CHAIR

• Andreas Shaefer, MD

  Hannover Medical School

  STUDY CHAIR

• Nikos Werner, MD

  University Hospital Trier

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Cardiology

Study Record Dates

• First Submitted: June 28, 2012
• First Posted: July 4, 2012
• Study Start: December 1, 2012
• Primary Completion: July 1, 2023
• Study Completion: April 1, 2024
• Last Updated: May 14, 2024

Record last verified: 2024-05

Locations

GB (1); DK (3); DE (9)