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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)

RecruitingNAAges 18 Years - anyAllBeijing Anzhen Hospital
NCT07352891 on ClinicalTrials.gov โ†—
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In plain words

What the trial is, and whether it could suit you

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 (โ‰ฅ18 years) with a confirmed diagnosis of HFrEF within the past 3 months (left ventricular ejection fraction โ‰ค40%) who are not optimally treated with GDMT-defined as at least two of the four foundational drug classes (ACEi/ARB or ARNi, ฮฒ-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, an

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Adults aged โ‰ฅ18 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 โ‰ค40% 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.
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What it tests

  • Digital Remote Management
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Where

6 sites
Beijing Anzhen Hospital, Capital Medical University, Beijing, China
Beijing, China
Beijing Tongren Hospital, Capital Medical University, Beijing, China
Beijing, China
The First Affiliated Hospital of Dalian Medical University, Dalian, China
Dalian, China
The First Hospital of Jilin University, Changchun, China
Jilin City, China
The Second Affiliated Hospital of Nanchang University, Nanchang, China
Nanchang, China
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
Shanghai, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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