Elsevier

American Heart Journal

Volume 214, August 2019, Pages 60-68
American Heart Journal

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

https://doi.org/10.1016/j.ahj.2019.04.019Get rights and content
Under a Creative Commons license
open access

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.

Cited by (0)

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

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.

1

Dr. Engstrøm and Hassager have contributed equally to senior authorship.