Rationale and design of DanGer shock: Danish-German cardiogenic shock trial

DanGer Shock investigators

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Abstract

Objective: The DanGer Shock trial test the hypothesis that left ventricular (LV) mechanical circulatory support with Impella CP transvalvular microaxial flow pump improves survival in patients with ST segment elevation acute myocardial infarction complicated by cardiogenic shock (AMICS) compared to conventional guideline-driven treatment. This paper describes the rationale and design of the randomized trial, in addition to the baseline characteristics of the population screened and enrolled so far. Methods: The DanGer Shock study is a prospective, multicenter, open-label trial in patients with AMICS randomized 1:1 to Impella CP or current guideline-driven therapy with planned enrollment of 360 patients. Patients comatose after out of hospital cardiac arrest are excluded. Eligible patients are randomized immediately following shock diagnosis. Among patients randomized to receive Impella CP, the device is placed prior to angioplasty. The primary endpoint is all-cause mortality at 180 days. Baseline characteristics of patients screened and randomized in the DanGer Shock as of June 2018 are compared with 2 contemporary AMICS studies. Results: As of end of June 2018, 314 patients were screened and 100 patients were randomized. Patients had median arterial lactate of 5.5 mmol/L (interquartile range 3.7-8.8 mmol/L), median systolic blood pressure of 76 mmHg (interquartile range 70-88 mmHg), and median LV ejection fraction of 20% (interquartile range 10%-30%). Conclusion: The DanGer Shock trial will be the first adequately powered randomized trial to address whether mechanical circulatory LV support with Impella CP can improve survival in AMICS. Baseline characteristics of the first 100 randomized patients indicate a population in profound cardiogenic shock.

Original languageEnglish
JournalAmerican Heart Journal
Volume214
Pages (from-to)60-68
ISSN0002-8703
DOIs
Publication statusPublished - 1. Aug 2019

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Cardiogenic Shock
Guidelines
Population Characteristics
Lactic Acid

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@article{925e2ce9cc5249fd88e69c1652deff06,
title = "Rationale and design of DanGer shock: Danish-German cardiogenic shock trial",
abstract = "Objective: The DanGer Shock trial test the hypothesis that left ventricular (LV) mechanical circulatory support with Impella CP transvalvular microaxial flow pump improves survival in patients with ST segment elevation acute myocardial infarction complicated by cardiogenic shock (AMICS) compared to conventional guideline-driven treatment. This paper describes the rationale and design of the randomized trial, in addition to the baseline characteristics of the population screened and enrolled so far. Methods: The DanGer Shock study is a prospective, multicenter, open-label trial in patients with AMICS randomized 1:1 to Impella CP or current guideline-driven therapy with planned enrollment of 360 patients. Patients comatose after out of hospital cardiac arrest are excluded. Eligible patients are randomized immediately following shock diagnosis. Among patients randomized to receive Impella CP, the device is placed prior to angioplasty. The primary endpoint is all-cause mortality at 180 days. Baseline characteristics of patients screened and randomized in the DanGer Shock as of June 2018 are compared with 2 contemporary AMICS studies. Results: As of end of June 2018, 314 patients were screened and 100 patients were randomized. Patients had median arterial lactate of 5.5 mmol/L (interquartile range 3.7-8.8 mmol/L), median systolic blood pressure of 76 mmHg (interquartile range 70-88 mmHg), and median LV ejection fraction of 20{\%} (interquartile range 10{\%}-30{\%}). Conclusion: The DanGer Shock trial will be the first adequately powered randomized trial to address whether mechanical circulatory LV support with Impella CP can improve survival in AMICS. Baseline characteristics of the first 100 randomized patients indicate a population in profound cardiogenic shock.",
author = "Udesen, {Nanna Junker} and M{\o}ller, {Jacob Eifer} and Lindholm, {Matias Greve} and Hans Eiskj{\ae}r and Andreas Sch{\"a}fer and Nikos Werner and Lene Holmvang and Terkelsen, {Christian Juhl} and Jensen, {Lisette Okkels} and Anders Junker and Henrik Schmidt and Kristian Wachtell and Holger Thiele and Thomas Engstr{\o}m and Christian Hassager and {DanGer Shock investigators}",
year = "2019",
month = "8",
day = "1",
doi = "10.1016/j.ahj.2019.04.019",
language = "English",
volume = "214",
pages = "60--68",
journal = "American Heart Journal",
issn = "0002-8703",
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Rationale and design of DanGer shock : Danish-German cardiogenic shock trial. / DanGer Shock investigators.

In: American Heart Journal, Vol. 214, 01.08.2019, p. 60-68.

Research output: Contribution to journalJournal articleResearchpeer-review

TY - JOUR

T1 - Rationale and design of DanGer shock

T2 - Danish-German cardiogenic shock trial

AU - Udesen, Nanna Junker

AU - Møller, Jacob Eifer

AU - Lindholm, Matias Greve

AU - Eiskjær, Hans

AU - Schäfer, Andreas

AU - Werner, Nikos

AU - Holmvang, Lene

AU - Terkelsen, Christian Juhl

AU - Jensen, Lisette Okkels

AU - Junker, Anders

AU - Schmidt, Henrik

AU - Wachtell, Kristian

AU - Thiele, Holger

AU - Engstrøm, Thomas

AU - Hassager, Christian

AU - DanGer Shock investigators

PY - 2019/8/1

Y1 - 2019/8/1

N2 - Objective: The DanGer Shock trial test the hypothesis that left ventricular (LV) mechanical circulatory support with Impella CP transvalvular microaxial flow pump improves survival in patients with ST segment elevation acute myocardial infarction complicated by cardiogenic shock (AMICS) compared to conventional guideline-driven treatment. This paper describes the rationale and design of the randomized trial, in addition to the baseline characteristics of the population screened and enrolled so far. Methods: The DanGer Shock study is a prospective, multicenter, open-label trial in patients with AMICS randomized 1:1 to Impella CP or current guideline-driven therapy with planned enrollment of 360 patients. Patients comatose after out of hospital cardiac arrest are excluded. Eligible patients are randomized immediately following shock diagnosis. Among patients randomized to receive Impella CP, the device is placed prior to angioplasty. The primary endpoint is all-cause mortality at 180 days. Baseline characteristics of patients screened and randomized in the DanGer Shock as of June 2018 are compared with 2 contemporary AMICS studies. Results: As of end of June 2018, 314 patients were screened and 100 patients were randomized. Patients had median arterial lactate of 5.5 mmol/L (interquartile range 3.7-8.8 mmol/L), median systolic blood pressure of 76 mmHg (interquartile range 70-88 mmHg), and median LV ejection fraction of 20% (interquartile range 10%-30%). Conclusion: The DanGer Shock trial will be the first adequately powered randomized trial to address whether mechanical circulatory LV support with Impella CP can improve survival in AMICS. Baseline characteristics of the first 100 randomized patients indicate a population in profound cardiogenic shock.

AB - Objective: The DanGer Shock trial test the hypothesis that left ventricular (LV) mechanical circulatory support with Impella CP transvalvular microaxial flow pump improves survival in patients with ST segment elevation acute myocardial infarction complicated by cardiogenic shock (AMICS) compared to conventional guideline-driven treatment. This paper describes the rationale and design of the randomized trial, in addition to the baseline characteristics of the population screened and enrolled so far. Methods: The DanGer Shock study is a prospective, multicenter, open-label trial in patients with AMICS randomized 1:1 to Impella CP or current guideline-driven therapy with planned enrollment of 360 patients. Patients comatose after out of hospital cardiac arrest are excluded. Eligible patients are randomized immediately following shock diagnosis. Among patients randomized to receive Impella CP, the device is placed prior to angioplasty. The primary endpoint is all-cause mortality at 180 days. Baseline characteristics of patients screened and randomized in the DanGer Shock as of June 2018 are compared with 2 contemporary AMICS studies. Results: As of end of June 2018, 314 patients were screened and 100 patients were randomized. Patients had median arterial lactate of 5.5 mmol/L (interquartile range 3.7-8.8 mmol/L), median systolic blood pressure of 76 mmHg (interquartile range 70-88 mmHg), and median LV ejection fraction of 20% (interquartile range 10%-30%). Conclusion: The DanGer Shock trial will be the first adequately powered randomized trial to address whether mechanical circulatory LV support with Impella CP can improve survival in AMICS. Baseline characteristics of the first 100 randomized patients indicate a population in profound cardiogenic shock.

U2 - 10.1016/j.ahj.2019.04.019

DO - 10.1016/j.ahj.2019.04.019

M3 - Journal article

C2 - 31176289

AN - SCOPUS:85066251828

VL - 214

SP - 60

EP - 68

JO - American Heart Journal

JF - American Heart Journal

SN - 0002-8703

ER -