Heart Failure With Reduced Ejection Fraction
Conditions
Brief 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 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).
Detailed description
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.
Interventions
OTHERDigital 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.
Sponsors
Beijing Anzhen Hospital
The First Hospital of Jilin University
Second Affiliated Hospital of Nanchang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adults aged ≥18 years. 2. Hospitalised at a secondary or tertiary hospital with established heart failure care capacity. 3. Diagnosed with HFrEF within the past 3 months according to the 2022 ACC/AHA/HFSA guideline diagnostic pathway, including: LVEF ≤40% by echocardiography; typical heart-failure symptoms and/or signs; and exclusion of non-HF causes of symptoms. 4. Not optimized on guideline-directed medical therapy (GDMT) at enrollment, defined as at least two of the following four foundational drug classes not initiated or administered at \<50% target dose. 5. Written informed consent provided.
Exclusion criteria
1. Absolute contraindication to heart failure pharmacotherapy. 2. History of heart transplantation or currently on a transplant waiting list. 3. Receiving or planning implantation of a left ventricular assist device. 4. Pregnant or breastfeeding women. 5. Organ transplantation within the past 12 months. 6. Unable to use the remote management platform as required (e.g., cognitive impairment or lack of caregiver support). 7. Unable to perform blood pressure or body-weight monitoring (e.g., severe limb disability). 8. Unable to express willingness or comply with follow-up requirements (e.g., unable to use internet-enabled devices). 9. Any other condition judged by the investigator to make the patient unsuitable for participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in hear failure GDMT score (ΔGDMT) from baseline to 3 months | 3 months after randomization | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart failure hospitalization | 3 months after randomization | — |
| Cardiovascular hospitalization | 3 months after randomization | — |
| Cardiovascular mortality | 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 | 3 months after randomization | 6-minute walk distance |
| Change in KCCQ score | 3 months after randomization | 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. |
| Change in EQ-5D-5L score | 3 months after randomization | 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. |
| 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 | — |
Countries
China
Contacts
CONTACTDigiCare-HFrEF Coordinating Center
Outcome results
None listed