Digital remote care to optimize heart-failure medicines after hospital discharge

Digital Remote Management for Care and Continuous Optimization Versus Usual Care for Optimization of Guideline-directed Medical Therapy in Patients With Heart Failure and Reduced Ejection Fraction (DigiCare-HFrEF): a Multicentre, Randomised, Controlled Trial

This trial will test whether a digital remote-management program helps adults recently hospitalized with HFrEF get their heart-failure medicines to recommended doses and avoid bad outcomes.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 252 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Beijing Anzhen Hospital (Academic / other)
• Locations: 6 sites (Beijing and 5 other locations)
• Trial ID: NCT07352891 on ClinicalTrials.gov

What this trial studies

DigiCare-HFrEF is a multicentre, randomised, open-label, endpoint-blinded superiority trial enrolling adults recently hospitalized with heart failure with reduced ejection fraction. Participants not already optimized on guideline-directed medical therapy are randomized 1:1 to a structured digital remote-management platform plus usual care or to usual care alone. The digital arm uses daily symptom and vital-sign reporting, algorithm-based risk stratification, and clinician-reviewed decision support to guide GDMT titration and congestion management. Follow-up includes a remote assessment at 1 month and an in-person visit at 3 months, with blinded adjudication of clinical events and measurement of medication optimization.

Who should consider this trial

Good fit: Adults (≥18) hospitalized at participating secondary or tertiary centres with confirmed HFrEF (LVEF ≤40%) within the past 3 months who are not yet optimized on at least two of the four foundational GDMT drug classes are ideal candidates.

Not a fit: Patients with absolute contraindications to heart-failure drugs, those listed for or with prior heart transplant or planned LVAD, pregnant or breastfeeding people, or those unable to use the remote platform are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, the program could help patients reach guideline-recommended medication doses faster and reduce hospital readmissions and major cardiac events.

How similar studies have performed: Similar digital and remote-monitoring approaches for heart failure have shown mixed but promising results, with some trials reporting reduced hospitalizations and better medication management while others found no clear benefit.

Eligibility criteria

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.

Where this trial is running

Beijing and 5 other locations

• Beijing Anzhen Hospital, Capital Medical University, Beijing, China — Beijing, China (Recruiting)
• Beijing Tongren Hospital, Capital Medical University, Beijing, China — Beijing, China (Recruiting)
• The First Affiliated Hospital of Dalian Medical University, Dalian, China — Dalian, China (Recruiting)
• The First Hospital of Jilin University, Changchun, China — Jilin, China (Recruiting)
• The Second Affiliated Hospital of Nanchang University, Nanchang, China — Nanchang, China (Not_yet_recruiting)
• Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China — Shanghai, China (Not_yet_recruiting)

Study contacts

• Study coordinator: DigiCare-HFrEF Coordinating Center

Conditions Heart Failure With Reduced Ejection Fraction