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Cardiogenic Shock AcuteDanShockNCT01633502

Danish Cardiogenic Shock Trial

A study testing Conventional circulatory support and Impella CP in people with Cardiogenic Shock Acute and Acute Myocardial Infarction, run by Odense University Hospital at 13 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Conventional circulatory support and Impella CP
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
360 participants
Where
13 sitesin 3 countries
Study dates
Dec 2012to Apr 2024
Phase
Interventional
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 9Show fewer
  • Known heparin intolerance.
  • Already established mechanical circulatory support
  • Do not resuscitate wish.

Trial locations and contacts

13 sites in 3 countries.

13 sites in 3 countries

Germany9 sites

  • Charite Berlin

    Berlin

  • University Hospital Bonn

    Bonn

  • Dresden University Hospital

    Dresden

  • Düsseldorf University Hospital

    Düsseldorf

  • UKE Hamburg

    Hamburg

  • Hannover Medical School

    Hanover

  • Jena University Hospital

    Jena

  • Brüderkrankenhaus Trier

    Trier

  • University Hospital Würzburg

    Würzburg

Other trials in Germany

Denmark3 sites

  • Aarhus University Hospital Skejby

    Aarhus, 8200

  • Copenhagen University Hospital Rigshospitalet

    Copenhagen, 2100

  • Odense University Hospital

    Odense, DK-5000

Other trials in Denmark

United Kingdom1 site

  • NHs Harefield Hospital

    London

Other trials in United Kingdom

About this study

Official title: Effects of Advanced Mechanical Circulatory Support in Patients With ST Segment Elevation Myocardial Infarction Complicated by Cardiogenic Shock. The Danish Cardiogenic Shock Trial

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.

Being tested
Conventional circulatory support, Impella CP

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Conventional circulatory supportDevice

    Also called Conventional circulatory support will be employed according to enrolling sites usual management.

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

  • Impella CPDevice

    Also called Impella CP, Abiomed

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

Study groups in NCT01633502
Study groupRoleWhat they receive
Conventional circulatory supportPlacebo comparatorPatients randomized to conventional circulatory support.
Receives: Device: Conventional circulatory support
ImpellaActive comparatorPatients randomized to Impella CP
Receives: Device: Impella CP

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Death

    Death from all causes

    Measured: up to 6 months

Secondary outcomes (3)

  1. MACE

    Major cardiovascular events, death, cardiac transplant, escalation to permanent left ventricular assist device, re-hospitalization for heart failure.

    Measured: minimum follow-up 6 months

  2. Composite saftey

    Combined safety comprising major bleeding, vascular complications, and significant hemolysis.

    Measured: up to 6 months

  3. Days alive out of hospital

    Days alive and out of hospital; calculated by subtracting the number of days spent in hospital, from time of randomization to end of follow-up (180 days) for each patient.

    Measured: up tp 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jul 2012 (estimated)
  2. Study startDec 2012
  3. Primary completionJul 2023
  4. Study completionApr 2024

Resources

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
Masking
None (open label)
Enrolment
360 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01633502
Sponsor's protocol ID
DanShock-01
Acronym
DanShock
Status last verified
May 2024
First submitted
28 Jun 2012
Last updated
14 May 2024
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 36272450

  • 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.

    PubMed 31176289

  • 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.

    PubMed 38587239

  • Zweck E, Beske RP, Hassager C, Jensen LO, Eiskjaer H, Mangner N, Polzin A, Schulze PC, Skurk C, Nordbeck P, Schrage B, Panoulas V, Zimmer S, Schafer A, Engstrom T, Holmvang L, Junker A, Schmidt H, Udesen NJ, Terkelsen CJ, Christensen S, Linke A, Westenfeld R, Moller JE; DanGer Shock Investigators. Microaxial Flow Pump Use in Different Phenotypes of Cardiogenic Shock-a Secondary Analysis of the DanGer Shock Trial. J Card Fail. 2026 Mar 3:S1071-9164(26)00083-7. doi: 10.1016/j.cardfail.2026.02.015. Online ahead of print.

    PubMed 41785958

  • Sorensen R, Moller JE, Vandenbriele C, Hassager C, Eiskjaer H, Mangner N, Polzin A, Schulze PC, Skurk C, Nordbeck P, Clemmensen P, Panoulas V, Zimmer S, Schafer A, Christensen S, Engstrom T, Beske RP, Frydland M, Jensen LO, Junker A, Schmidt H, Udesen NLJ, Terkelsen CJ, Linke A, Holmvang L; DanGer Shock Investigators. Bleeding in Patients With Infarct-Related Cardiogenic Shock: A DanGer Shock Substudy. JACC Cardiovasc Interv. 2026 Feb 9;19(3):302-312. doi: 10.1016/j.jcin.2025.10.051.

    PubMed 41672689

  • 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 Mar;19(3):e015718. doi: 10.1161/CIRCINTERVENTIONS.125.015718. Epub 2026 Jan 12.

    PubMed 41521915

  • 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. 2026 Feb 17;87(6):704-719. doi: 10.1016/j.jacc.2025.09.019. Epub 2025 Nov 12.

    PubMed 41222528

  • 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.

    PubMed 40884241

  • 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.

    PubMed 40562510

  • 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.

    PubMed 39551167

  • 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.

    PubMed 39462276

  • 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.

    PubMed 39462240

Questions about this trial

What is this clinical trial studying?

A study testing Conventional circulatory support and Impella CP in people with Cardiogenic Shock Acute and Acute Myocardial Infarction, run by Odense University Hospital at 13 sites in 3 countries.

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 5 inclusion and 9 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: finished, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Germany, Denmark, United Kingdom. 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. Some participants in this study may receive a placebo. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Death (time frame: up to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01633502, which also lists 12 linked publications.

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 14 May 2024.

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