Actively Recruiting
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)
Led by Beijing Anzhen Hospital · Updated on 2026-04-24
252
Participants Needed
6
Research Sites
N/A
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
Researchers are evaluating a digital remote-management platform for adults with heart failure with reduced ejection fraction (HFrEF), specifically those diagnosed within the past 3 months who are not yet optimally treated with guideline-directed medical therapy (GDMT). This multicenter, randomized, open-label trial aims to see if this digital approach can better optimize GDMT compared to usual care after hospital discharge. The study focuses on improving medication management and early detection of health changes to reduce complications in HFrEF patients. Participants will be randomly assigned to either usual care, involving standard outpatient follow-up without digital support, or to an intervention group using a digital platform. Those in the intervention group will report daily symptoms and vital signs such as blood pressure and weight through the platform. An algorithm analyzes this information to suggest medication adjustments and manage fluid congestion, which clinicians review and confirm before advising patients. Follow-up includes remote assessments at 1 month and in-person visits at 3 months. During the study, participants will undergo regular monitoring of their symptoms, vital signs, and medication adherence through the platform or usual care visits. Researchers will measure changes in GDMT scores over 3 months to assess therapy optimization. Secondary outcomes include hospitalizations, mortality, biomarker changes, functional capacity, and quality of life. The study includes safety monitoring and aims to provide insights into improving heart failure management over the trial period.
CONDITIONS
Brief 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 18 years or older
- Hospitalised at a secondary or tertiary hospital with established heart failure care capacity
- Diagnosed with heart failure with reduced ejection fraction within the past 3 months according to guidelines, including left ventricular ejection fraction of 40% or less
- Not optimally treated with guideline-directed medical therapy, defined as at least two of the four key drug classes not started or prescribed below 50% of the target dose
- Provided written informed consent
You will not qualify if you...
- Absolute contraindication to heart failure medications
- History of heart transplantation or currently on a transplant waiting list
- Receiving or planning to receive a left ventricular assist device
- Pregnant or breastfeeding women
- Organ transplantation within the past 12 months
- Unable to use the remote management platform, such as due to cognitive impairment or lack of caregiver support
- Unable to perform blood pressure or body weight monitoring, such as severe limb disability
- Unable to express willingness or comply with follow-up requirements, including inability to use internet-enabled devices
- Any other condition that makes participation unsuitable as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 months
Participants receive either digital remote management with daily symptom and vital-sign reporting plus clinician support, or usual care with standard guideline-recommended outpatient follow-up.
Standardised remote assessments at 1 month and face-to-face visits at 3 months
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 City, 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
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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