Danish Cardiogenic Shock Trial

NCT ID: NCT01633502

Last Updated: 2024-05-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 360 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2024-04-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Conventional circulatory support

Patients randomized to conventional circulatory support.

Group Type: PLACEBO_COMPARATOR

Conventional circulatory support

Intervention Type: DEVICE

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

Impella

Patients randomized to Impella CP

Group Type: ACTIVE_COMPARATOR

Impella CP

Intervention Type: DEVICE

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

Interventions

Conventional circulatory support

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

Intervention Type: DEVICE

Impella CP

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

Intervention Type: DEVICE

Other Intervention Names

Conventional circulatory support will be employed according to enrolling sites usual management.; Impella CP, Abiomed

Eligibility Criteria

Inclusion Criteria

1. 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

2. 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

3. Left ventricular ejection fraction of less than 45% visually estimated or by wall motion score index >1,6.

Exclusion Criteria

1. Other causes of shock (hypovolemia, hemorrhage, sepsis, pulmonary embolism or anaphylaxis).

2. Shock due to mechanical complication to myocardial infarction (papillary muscle rupture, rupture of the ventricular septum or rupture of free wall).

3. Severe aorta valve regurgitation/stenosis.

4. Predominant right ventricular failure.

5. Out of hospital cardiac arrest with persistent Glasgow coma scale <8 after return of spontaneous circulation.

6. Shock duration>24 hours.

7. Known heparin intolerance.

8. Already established mechanical circulatory support

9. Do not resuscitate wish.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aarhus University Hospital Skejby

OTHER

Sponsor Role: collaborator

Hannover Medical School

OTHER

Sponsor Role: collaborator

University Hospital, Bonn

OTHER

Sponsor Role: collaborator

Jena University Hospital

OTHER

Sponsor Role: collaborator

University Hospital Dresden

OTHER

Sponsor Role: collaborator

Heinrich-Heine University, Duesseldorf

OTHER

Sponsor Role: collaborator

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role: collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role: collaborator

Royal Brompton & Harefield NHS Foundation Trust

OTHER

Sponsor Role: collaborator

Wuerzburg University Hospital

OTHER

Sponsor Role: collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role: collaborator

Odense University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jacob Moller

Professor in Cardiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jacob E Moller, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiology, Odense University Hospital, Odense

Anders Junker, MD

Role: STUDY_CHAIR

Department of Cardiology, Odense University Hospital

Christian Hassager, MD

Role: STUDY_CHAIR

Department of Cardiology, Copenhagen University Hospital Gentofte

Andreas Shaefer, MD

Role: STUDY_CHAIR

Hannover Medical School

Nikos Werner, MD

Role: STUDY_CHAIR

University Hospital Trier

Locations

Aarhus University Hospital Skejby

Aarhus, , Denmark

Copenhagen University Hospital Rigshospitalet

Copenhagen, , Denmark

Odense University Hospital

Odense, , Denmark

Charite Berlin

Berlin, , Germany

University Hospital Bonn

Bonn, , Germany

Dresden University Hospital

Dresden, , Germany

Düsseldorf University Hospital

Düsseldorf, , Germany

UKE Hamburg

Hamburg, , Germany

Hannover Medical School

Hanover, , Germany

Jena University Hospital

Jena, , Germany

Brüderkrankenhaus Trier

Trier, , Germany

University Hospital Würzburg

Würzburg, , Germany

NHs Harefield Hospital

London, , United Kingdom

Countries

Denmark; Germany; United Kingdom

References

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.

Reference Type: BACKGROUND

PMID: 36272450 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31176289 (View on PubMed)

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.

Reference Type: RESULT

PMID: 38587239 (View on PubMed)

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 Aug 30:e253337. doi: 10.1001/jamacardio.2025.3337. Online ahead of print.

Reference Type: DERIVED

PMID: 40884241 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 40562510 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 39551167 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 39462276 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 39462240 (View on PubMed)

Other Identifiers

DanShock-01

Identifier Type: -

Identifier Source: org_study_id