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Compares treatment options for Heart Failure With Reduced Ejection Fraction
Official 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)
ClinicalTrials.gov ID: NCT07352891
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Not optimized on guideline-directed medical therapy (GDMT) at enrollment, defined as at least two of the following four foundational drug classes not...
- Written informed consent provided.
You likely can't join if
- Absolute contraindication to heart failure pharmacotherapy.
- History of heart transplantation or currently on a transplant waiting list.
- Receiving or planning implantation of a left ventricular assist device.
- Pregnant or breastfeeding women.
- Organ transplantation within the past 12 months.
- Unable to use the remote management platform as required (e.g., cognitive impairment or lack of caregiver support).
See the full eligibility criteria
- 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...
- 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.
- Absolute contraindication to heart failure pharmacotherapy.
- History of heart transplantation or currently on a transplant waiting list.
- Receiving or planning implantation of a left ventricular assist device.
- Pregnant or breastfeeding women.
- Organ transplantation within the past 12 months.
- Unable to use the remote management platform as required (e.g., cognitive impairment or lack of caregiver support).
- 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).
- Any other condition judged by the investigator to make the patient unsuitable for participation.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
- Dalian, China
- Jilin City, China
- Nanchang, China
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China; Dalian, China; Jilin City, China; Nanchang, China; Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.