Digital Remote Management Versus Usual Care for Optimization of Guideline-directed Medical
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)
| Condition(s) | Heart Failure With Reduced Ejection Fraction |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | 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 a |
| Who can participate | 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. Receivi |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Beijing Anzhen Hospital |
| Locations | Beijing, China; Beijing, China; Dalian, China; Jilin City, China; Nanchang, China; Shanghai, China |
| Start date | 2026-02-26 |
| NCT ID | NCT07352891 |
| Official listing | https://clinicaltrials.gov/study/NCT07352891 |