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
Sponsor: Beijing Anzhen Hospital
Trial Details
| Condition | Heart Failure With Reduced Ejection Fraction |
| Intervention | Digital Remote Management |
| Phase | NA |
| Status | Recruiting |
| Participants | 252 |
| Est. Completion | 1 July 2026 |
| Last Updated | 24 Apr 2026 |
Primary Outcome
Change in hear failure GDMT score (ΔGDMT) from baseline to 3 months
Eligibility Criteria
Inclusion Criteria
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.
Trial Sites
Countries
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