Digital Remote Management for Care and Continuous Optimization Versus Usual Care to Improve Prognosis in Patients With Heart Failure With Reduced Ejection Fraction

DigiCare-HFrEF is an investigator-initiated, multicentre, randomised, open-label, endpoint-blinded, superiority trial designed to evaluate whether a structured digital remote-management platform can improve clinical outcomes in patients with heart failure with reduced ejection fraction (HFrEF) after hospital discharge. Eligible adults with LVEF ≤40% within past 3 months, NYHA class II-IV, and elevated natriuretic peptides (NT-proBNP \>2500 pg/mL or BNP \>600 pg/mL) will be randomly assigned (1:1) to digital remote management or to usual care. In the intervention arm, patients will report symptoms and key physiologic measures (e.g., blood pressure and body weight) via the platform; an algorithm will perform risk stratification and generate guideline-directed medical therapy (GDMT) optimisation suggestions and decongestion prompts, as well as a comprehensive management for core health metrics, which are reviewed and confirmed by clinicians before implementation. The primary endpoint is the composite of cardiovascular death or first heart-failure event (hospitalisation or urgent visit for heart failure) at 12 months.

"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 and 6 months and face-to-face visits at 3 and 12 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."