NCT07352891Recruiting
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)
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
Source: ClinicalTrials.gov · Last updated 24 Apr 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 252 (estimated)
- First submitted
- 31 Dec 2025
- Start date
- 26 Feb 2026
- Primary completion date
- 31 Jul 2026
- Lead sponsor
- Beijing Anzhen Hospital
- Diseases
- Heart failure
- NCT number
- NCT07352891
What you commit to
- Study type: Interventional
- Planned participants: 252
- From 26 Feb 2026 to the primary completion date, 31 Jul 2026
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of heart transplantation or currently on a transplant waiting list.
- Receiving or planning implantation of a left ventricular assist device.
- Organ transplantation within the past 12 months.
Other illness
- Absolute contraindication to heart failure pharmacotherapy.
- Unable to use the remote management platform as required (e.g., cognitive impairment or lack of caregiver support).
- Any other condition judged by the investigator to make the patient unsuitable for participation.
Other
- Pregnant or breastfeeding women.
- 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).
Who the study is looking for
- Adults aged ≥18 years.
- Hospitalised at a secondary or tertiary hospital with established heart failure care capacity.
- 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.
- 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.
- Written informed consent provided.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Anzhen Hospital, Capital Medical University, Beijing, China Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Beijing Tongren Hospital, Capital Medical University, Beijing, China Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| The First Affiliated Hospital of Dalian Medical University, Dalian, China Coordinator of this site? Confirm its status | Dalian | China | Recruiting |
| The First Hospital of Jilin University, Changchun, China Coordinator of this site? Confirm its status | Jilin City | China | Recruiting |
| The Second Affiliated Hospital of Nanchang University, Nanchang, China Coordinator of this site? Confirm its status | Nanchang | China | Not yet recruiting |
| Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China Coordinator of this site? Confirm its status | Shanghai | China | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.