Background: Despite a range of devices, medical interventions, and revascularization techniques utilized in cardiogenic shock (CS), there is a lack of evidence guiding management. We sought to characterize the contemporary trials through utilization of the ClinicalTrials.gov database.
Methods: We investigated all phase II-IV interventional trials in the ClinicalTrials.gov database through June 29, 2019 that enrolled patients with CS. Published trials investigating medical interventions were evaluated for methodological quality using the Jadad scoring system.
Results: The initial query yielded 28 registered studies, of which 28 directly studied CS through whole or subgroup analyses. Of these, five were withdrawn or terminated, while 13 were recruiting, not yet recruiting, or were of unknown recruitment status. The remaining 10 were published and had a median patient size of 69 patients and a median site size of 6. Of the published studies, all-cause mortality was the most common primary endpoint (60%), including composite endpoints that included mortality. The remaining endpoints examined surrogate hemodynamic parameters of cardiac function through echocardiography. The mean Jadad score of the published trials investigating pharmacological therapies was 2.42. Of the trials investigating device therapies or revascularization methods, all were randomized, parallel-arm studies that were open label.
Conclusions: Modern trials vary from single center to multicenter and are small in size. The primary endpoints were clinical, focusing on mortality and restoration of cardiac output or cardiac index. Methodological quality varies in the trials focused on pharmacologic therapy. Trials with devices or revascularization do not employ blinding, but do employ randomization.
Keywords: cardiogenic shock; circulatory support devices; guidelines.