Condition: Heart Failure With Reduced Ejection Fraction · Sponsor: Beijing Anzhen Hospital
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).
This description comes directly from the study's public registry record.
DigiCare-HFrEF Coordinating Center · chshma@vip.sina.com · chshma@vip.sina.com
Always discuss trial participation with your own doctor first.
| 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 |
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Source record: clinicaltrials.gov/study/NCT07352891