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)

Chang sheng Ma

Status: Not yet enrolling

Conditions: Heart Failure With Reduced Ejection Fraction

Treatments: Other: Digital Remote Management

Study type: Interventional

Funder types: Other

Identifiers

NCT07352891

KS2025289

Details and patient eligibility

About

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.

Full 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 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."

Enrollment: 774 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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. NT-proBNP >2500 pg/mL or BNP >600 pg/mL.
5. NYHA functional class II-IV.
6. 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. Estimated life expectancy <1 year.
10. Any other condition judged by the investigator to make the patient unsuitable for participation."

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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774 participants in 2 patient groups

Usual Care

No Intervention group

Description:

Usual Care with guideline-recommended outpatient follow-up. No platform-based risk stratification or decision support is provided.

Digital Remote Management

Experimental group

Description:

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.

Treatment:

Other: Digital Remote Management