Remote digital care to improve heart failure medicines after hospital discharge
Tests a remote digital platform for adjusting medicines in adults with heart failure.
Plain-language title generated from the registry record
Registry title: Digital Remote Management Versus Usual Care for Optimization of Guideline-directed Medical Therapy in Patients With Heart Failure and Reduced Ejection Fraction: a Multicentre, Randomised, Controlled Trial (DigiCare-HFrEF)
Key facts
- Where
- Beijing, Dalian, Jilin City, Nanchang, and Shanghai, ChinaSee the 6 sites
Where in China
- Beijing Anzhen Hospital, Capital Medical University, Beijing, ChinaBeijing, ChinaTaking people
- Beijing Tongren Hospital, Capital Medical University, Beijing, ChinaBeijing, ChinaTaking people
- The First Affiliated Hospital of Dalian Medical University, Dalian, ChinaDalian, ChinaTaking people
- The First Hospital of Jilin University, Changchun, ChinaJilin City, ChinaTaking people
- The Second Affiliated Hospital of Nanchang University, Nanchang, ChinaNanchang, ChinaNot yet recruiting
- Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, ChinaShanghai, ChinaNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Beijing Anzhen Hospital
- Trial code
- NCT07352891
- Record updated
- 24 April 2026
- Original description
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).Read full original descriptionShow less
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
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).
Inclusion: Adults aged ≥18 years; Hospitalised at a secondary or tertiary hospital with established heart failure care capacity; 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; 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; Written informed consent provided.
Exclusion: History of heart transplantation or currently on a transplant waiting list; Receiving or planning implantation of a left ventricular assist device; Organ transplantation within the past 12 months; Absolute contraindication to heart failure pharmacotherapy; Unable to use the remote management platform as required (e.g., cognitive impairment or lack of caregiver support); Any other condition judged by the investigator to make the patient unsuitable for participation; Pregnant or breastfeeding women; Unable to perform blood pressure or body-weight monitoring (e.g., severe limb disability); Unable to express willingness or comply with follow-up requirements (e.g., unable to use internet-enabled devices).