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."
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
774
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.
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
Composite of cardiovascular death or first heart failure event
hospitalisation or urgent visit for heart failure
Time frame: 12 months after randomization
Change in hear failure GDMT score (ΔGDMT) from baseline to 3 months
The Guideline-Directed Medical Therapy (GDMT) Score is a modified heart-failure pharmacotherapy score based on five medication classes: 1. angiotensin-converting enzyme inhibitors or angiotensin receptor blockers (ACEi/ARB), 2. angiotensin receptor-neprilysin inhibitor (ARNI), 3. beta-blockers (BB), 4. mineralocorticoid receptor antagonists (MRA), and 5. sodium-glucose cotransporter-2 inhibitors (SGLT2i). Dosing levels are scored as follows: * ACEi/ARB: 0 = none; 0 = \<50% target dose; 1 = ≥50% target dose. * ARNI: 0 = none; 1 = \<50% target dose; 2 = ≥50% target dose. * Beta-blocker: 0 = none; 1 = \<50% target dose; 2 = ≥50% target dose. * MRA: 0 = none; 1 = \<50% target dose; 2 = ≥50% target dose. * SGLT2 inhibitor: 0 = none; 2 = therapeutic dose (no low-dose category). The total GDMT Score ranges from 0 to 9, with higher scores indicating more complete, optimized, and guideline-concordant HF medical therapy.
Time frame: 3 months after randomization
First heart failure hospitalization
Time frame: 3 months after randomization
First urgent visit for heart failure
Time frame: 3 months after randomization
Total heart failure hospitalizations
Time frame: 3 months after randomization
Total urgent visits for heart failure
Time frame: 3 months after randomization
First cardiovascular hospitalization
Time frame: 3 months after randomization
First all-cause hospitalization
Time frame: 3 months after randomization
All-cause mortality
Time frame: 3 months after randomization
First heart failure hospitalization
Time frame: 12 months after randomization
First urgent visit for heart failure
Time frame: 12 months after randomization
Total heart failure hospitalizations
Time frame: 12 months after randomization
Total urgent visits for heart failure
Time frame: 12 months after randomization
First cardiovascular hospitalization
Time frame: 12 months after randomization
First all-cause hospitalization
Time frame: 12 months after randomization
All-cause mortality
Time frame: 12 months after randomization
Change in NT-proBNP from baseline
Time frame: 12 months after randomization
Change in functional capacity (6-minute walk distance)
Time frame: 12 months after randomization
Change in KCCQ score
The Kansas City Cardiomyopathy Questionnaire-23 (KCCQ-23) is a 23-item patient-reported outcome measure of heart-failure-specific health status (symptoms, physical and social limitations, and quality of life). Each item is rated on a 5-point Likert scale (1 = extremely limited to 5 = not at all limited; response options such as "limited for other reasons or did not do this activity" are treated as missing). Domain scores are transformed to a 0-100 scale, and the overall summary score ranges from 0 to 100, with higher scores indicating better health status and fewer symptoms.
Time frame: 12 months after randomization
Change in MLHFQ score
The Minnesota Living With Heart Failure Questionnaire (MLHFQ) is a 21-item instrument assessing heart-failure-related quality of life. Each item is scored from 0 ("no impact") to 5 ("very much"). The total score ranges from 0 to 105, with higher scores indicating worse quality of life.
Time frame: 12 months after randomization
Change in EQ-5D-5L score
The EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) describes health status in five domains (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each rated on 5 levels (1 = no problems to 5 = extreme problems). A utility index score is derived using the Chinese value set, with values ranging approximately from -0.281 to 1.000, and an accompanying visual analogue scale (VAS) score ranging from 0 to 100, where higher scores on both the index and the VAS indicate better health status.
Time frame: 12 months after randomization
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