Effect of Digital Out-of-Hospital Care on Outcomes in Adults With Early Cardiogenic Shock A Multi-Center Randomized Trial

What this Trial Is About

Researchers are studying patients with early-stage cardiogenic shock to evaluate the impact of digital out-of-hospital management on clinical outcomes. This multi-center, open-label, randomized controlled trial compares a new digital management approach with standard discharge guidance. The study aims to assess whether this digital system can reduce one-year all-cause mortality and unplanned hospital readmissions, alongside other heart-related events and medication management outcomes. Participants are randomly assigned to either an experimental group using the HeartMed-HF digital out-of-hospital management system or a control group receiving usual discharge care. The digital management includes symptom monitoring, real-time vital sign tracking via a chip-implanted sphygmomanometer, and telemedicine support with clinical decision algorithms. Patients in the experimental group receive tailored management based on risk stratification and daily monitoring, while the control group follows standard post-discharge guidance. Throughout the 12-month study period, participants undergo regular assessments of survival, rehospitalizations, heart attacks, strokes, bleeding events, and medication use. Data is collected continuously through the digital platform for the experimental group and by standard follow-up for all. The primary outcomes focus on mortality and unplanned readmission within one year, with secondary measures including heart failure rehospitalization, ischemic events, and achievement of medication targets. This comprehensive monitoring aims to provide insight into how digital management may influence patient health after early cardiogenic shock.

Digital Out-of-hospital Management on Clinical Outcomes in Patients With Early Cardiogenic Shock