Actively Recruiting
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)
Led by Beijing Anzhen Hospital · Updated on 2026-04-24
252
Participants Needed
6
Research Sites
17 weeks
Total Duration
On this page
Sponsors
B
Beijing Anzhen Hospital
Lead Sponsor
T
The First Hospital of Jilin University
Collaborating Sponsor
AI-Summary
What this Trial Is 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 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).
CONDITIONS
Official 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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 6518 years.
- Hospitalised at a secondary or tertiary hospital with established heart failure care capacity.
- Diagnosed with heart failure with reduced ejection fraction (HFrEF) within the past 3 months according to guidelines, including LVEF 6540% by echocardiography, typical symptoms/signs, and exclusion of other causes.
- Not optimized on guideline-directed medical therapy (GDMT) at enrollment, defined as at least two of the four foundational drug classes not initiated or given at less than 50% target dose.
- Written informed consent provided.
You will not qualify if you...
- Absolute contraindication to heart failure pharmacotherapy.
- History of heart transplantation or currently on a transplant waiting list.
- Receiving or planning implantation of a left ventricular assist device.
- Pregnant or breastfeeding women.
- Organ transplantation within the past 12 months.
- Unable to use the remote management platform as required (e.g., cognitive impairment or lack of caregiver support).
- 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).
- Any other condition judged by the investigator to make the patient unsuitable for participation.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 6 locations
1
Beijing Anzhen Hospital, Capital Medical University, Beijing, China
Beijing, China
Actively Recruiting
2
Beijing Tongren Hospital, Capital Medical University, Beijing, China
Beijing, China
Actively Recruiting
3
The First Affiliated Hospital of Dalian Medical University, Dalian, China
Dalian, China
Actively Recruiting
4
The First Hospital of Jilin University, Changchun, China
Jilin, China
Actively Recruiting
5
The Second Affiliated Hospital of Nanchang University, Nanchang, China
Nanchang, China
Not Yet Recruiting
6
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
Shanghai, China
Not Yet Recruiting
Research Team
D
DigiCare-HFrEF Coordinating Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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