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)

Heart failure with reduced ejection fraction (HFrEF) remains associated with high rates of early post-discharge events. In routine practice, timely optimisation of guideline-directed medical therapy (GDMT) and early recognition of haemodynamic deterioration are frequently limited by infrequent follow-up, delayed access to physiologic data, and variability in patient self-management. DigiCare-HFrEF will enroll hospitalised patients with confirmed HFrEF and randomise them to either: 1. digital remote management based on an integrated platform that supports daily symptom and vital-sign reporting, algorithm-driven risk stratification, and clinician-reviewed decision support for GDMT titration and congestion management, plus standard guideline-based care; or 2. usual care with medical therapy and regular follow-up. Randomisation will be performed through a central web-based system with stratification by participating centre and age (≤65 vs \>65 years). Given the nature of the intervention, treatment allocation is open label; however, outcome assessment and event adjudication will be performed by independent personnel blinded to treatment assignment. Participants will be followed with standardised remote assessments at 1 months and face-to-face visits at 3 months. The trial will test whether a closed-loop digital care pathway-continuous monitoring, rapid risk-informed evaluation, and standardised responses with clinician oversight-reduces major clinical events and improves GDMT optimisation.