Digital Remote Management to Improve Heart Failure Therapy in Adults With Reduced Ejection Fraction A Multicenter Randomized Trial

What this Trial Is About

Researchers are evaluating a digital remote-management platform for adults with heart failure with reduced ejection fraction HFrEF, specifically those diagnosed within the past 3 months who are not yet optimally treated with guideline-directed medical therapy GDMT. This multicenter, randomized, open-label trial aims to see if this digital approach can better optimize GDMT compared to usual care after hospital discharge. The study focuses on improving medication management and early detection of health changes to reduce complications in HFrEF patients. Participants will be randomly assigned to either usual care, involving standard outpatient follow-up without digital support, or to an intervention group using a digital platform. Those in the intervention group will report daily symptoms and vital signs such as blood pressure and weight through the platform. An algorithm analyzes this information to suggest medication adjustments and manage fluid congestion, which clinicians review and confirm before advising patients. Follow-up includes remote assessments at 1 month and in-person visits at 3 months. During the study, participants will undergo regular monitoring of their symptoms, vital signs, and medication adherence through the platform or usual care visits. Researchers will measure changes in GDMT scores over 3 months to assess therapy optimization. Secondary outcomes include hospitalizations, mortality, biomarker changes, functional capacity, and quality of life. The study includes safety monitoring and aims to provide insights into improving heart failure management over the trial period.

Digital Remote Management Versus Usual Care for Optimization of Guideline-directed Medical Therapy in Patients With Heart Failure and Reduced Ejection Fraction: a Multicentre, Randomised, Controlled Trial (DigiCare-HFrEF)