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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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 City, 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
• Email: chshma@vip.sina.com
• Phone: chshma@vip.sina.com

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• HFrEF polypill strategy in Sri Lanka

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.