Rationale and design of DanGer shock: Danish-German cardiogenic shock trial - 14/07/19
, Matias Greve Lindholm, MD, PhD b, Hans Eiskjær, MD, DmSc c, Andreas Schäfer, MD d, Nikos Werner, MD, PhD e, Lene Holmvang, MD, DmSc b, Christian Juhl Terkelsen, MD, PhD, DmScc c, Lisette Okkels Jensen, MD, PhD, DmSca a, Anders Junker, MD, PhD a, Henrik Schmidt, MD, DmSc a, Kristian Wachtell, MD, PhD, DmSc f, Holger Thiele, MD g, Thomas Engstrøm, MD, PhD, DmSc b, 1, Christian Hassager, MD, PhD, DmSc b, 1on behalf of
DanGer Shock investigators
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.
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| Funding: The study has been supported by a grant from Danish Heart Foundation (12-04-R90-A3960-22700) and a research grant from founder Abiomed. RCT# NCT01633502 |
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| Disclosures: JEM and AS received speakers fee and a research grant from Abiomed; NW received speakers fee from Abiomed; NJU, MGL, HE, AS, NW, LH, CJT, LOJ, AJ, HS, KW, HT, TE, CH declare no conflicts of interest. |
Vol 214
P. 60-68 - août 2019 Retour au numéro
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