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Digital Remote Management for Care and Continuous Optimization Versus Usual Care to Improve Prognosis in Patients With Heart Failure With Reduced Ejection Fraction
Sponsor: Chang sheng Ma
Summary
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.
Official title: 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): A Multicentre, Randomised, Controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
774
Start Date
2026-01
Completion Date
2027-07
Last Updated
2026-01-20
Healthy Volunteers
No
Interventions
Digital Remote Management
Participants will use a digital remote-management platform to report symptoms and key physiologic variables (e.g., blood pressure and body weight). The platform applies a predefined risk-stratification algorithm and provides clinician-facing decision support for GDMT titration and congestion management. A comprehensive management for core health metrics will also be provided. Clinicians review and confirm recommendations before they are communicated to patients.
Locations (6)
Beijing Anzhen Hospital, Capital Medical University, Beijing, China
Beijing, China
Beijing Tongren Hospital, Capital Medical University, Beijing, China
Beijing, China
The First Affiliated Hospital of Dalian Medical University, Dalian, China
Dalian, China
The First Hospital of Jilin University, Changchun, China
Jilin, China
The Second Affiliated Hospital of Nanchang University, Nanchang, China
Nanchang, China
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
Shanghai, China