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| Name | Class |
|---|---|
| The First Hospital of Jilin University | OTHER |
| Second Affiliated Hospital of Nanchang University | OTHER |
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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 optimise guideline-directed medical therapy (GDMT) in patients with heart failure with reduced ejection fraction (HFrEF) after hospital discharge. Eligible adults (≥18 years) with a confirmed diagnosis of HFrEF within the past 3 months (left ventricular ejection fraction ≤40%) who are not optimally treated with GDMT-defined as at least two of the four foundational drug classes (ACEi/ARB or ARNi, β-blocker, MRA, SGLT2 inhibitor) either not initiated or prescribed at <50% of the target dose-will be randomly assigned in a 1:1 ratio to digital remote management or usual care. In the intervention arm, patients will report symptoms and key physiologic measures (e.g., blood pressure, heart rate, and body weight) via the platform; an algorithm will perform risk stratification and generate 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 change in GDMT score from baseline to 3 months (ΔGDMT).
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | No Intervention | Usual Care with guideline-recommended outpatient follow-up. No platform-based risk stratification or decision support is provided. | |
| Digital Remote Management | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital Remote Management | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
Dosing levels are scored as follows:
| 3 months after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Heart failure hospitalization | 3 months after randomization | |
| Cardiovascular hospitalization | 3 months after randomization | |
| Cardiovascular mortality |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| DigiCare-HFrEF Coordinating Center | Contact | chshma@vip.sina.com | chshma@vip.sina.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anzhen Hospital, Capital Medical University, Beijing, China | Recruiting | Beijing | China | |||
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| 3 months after randomization |
| All-cause mortality | 3 months after randomization |
| Change in NT-proBNP from baseline | 3 months after randomization |
| Change in functional capacity | 6-minute walk distance | 3 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. | 3 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. | 3 months after randomization |
| Proportion of patients with heart failure with improved ejection fraction (HFimpEF, LVEF increased by 10% to >40%) | 3 months after randomization |
| Emergency department visits and hospitalizations related to evidence-based medical therapies for HFrEF including symptomatic hypotension, hyperkalemia, and angioedema | 3 months after randomization |
| Beijing Tongren Hospital, Capital Medical University, Beijing, China |
| Recruiting |
| Beijing |
| China |
| The First Affiliated Hospital of Dalian Medical University, Dalian, China | Recruiting | Dalian | China |
| The First Hospital of Jilin University, Changchun, China | Recruiting | Jilin City | China |
| The Second Affiliated Hospital of Nanchang University, Nanchang, China | Not yet recruiting | Nanchang | China |
| Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China | Not yet recruiting | Shanghai | China |