Heart Failure With Reduced Ejection FractionDigiCare-HFrEFNCT07352891
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)
A study testing Digital Remote Management in people with Heart Failure With Reduced Ejection Fraction, run by Beijing Anzhen Hospital at 6 sites in China.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure With Reduced Ejection Fraction
- What is being tested?
- Digital Remote Management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 6 sitesChina
- Study dates
- 26 Feb 2026to Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 9Show fewer
- 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.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
China6 sites, 6 recruiting
- Recruiting
Beijing Anzhen Hospital, Capital Medical University, Beijing, China
Beijing
- Recruiting
Beijing Tongren Hospital, Capital Medical University, Beijing, China
Beijing
- Recruiting
The First Affiliated Hospital of Dalian Medical University, Dalian, China
Dalian
- Recruiting
The First Hospital of Jilin University, Changchun, China
Jilin City
- Not yet recruiting
The Second Affiliated Hospital of Nanchang University, Nanchang, China
Nanchang
- Not yet recruiting
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
Shanghai
About this study
Official title: 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
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).
Read the detailed description
Heart failure with reduced ejection fraction (HFrEF) remains associated with high rates of early post-discharge events. In routine practice, timely optimisation of guideline-directed medical therapy (GDMT) and early recognition of haemodynamic deterioration are frequently limited by infrequent follow-up, delayed access to physiologic data, and variability in patient self-management.
DigiCare-HFrEF will enroll hospitalised patients with confirmed HFrEF and randomise them to either:
- digital remote management based on an integrated platform that supports daily symptom and vital-sign reporting, algorithm-driven risk stratification, and clinician-reviewed decision support for GDMT titration and congestion management, plus standard guideline-based care; or
- usual care with medical therapy and regular follow-up.
Randomisation will be performed through a central web-based system with stratification by participating centre and age (≤65 vs >65 years). Given the nature of the intervention, treatment allocation is open label; however, outcome assessment and event adjudication will be performed by independent personnel blinded to treatment assignment. Participants will be followed with standardised remote assessments at 1 months and face-to-face visits at 3 months. The trial will test whether a closed-loop digital care pathway-continuous monitoring, rapid risk-informed evaluation, and standardised responses with clinician oversight-reduces major clinical events and improves GDMT optimisation.
- Being tested
- Digital Remote Management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Remote ManagementOther
Participants will use a digital remote-management platform to report symptoms and key physiologic variables (e.g., blood pressure and body weight). The platform applies a predefined risk-stratification algorithm and provides clinician-facing decision support for GDMT titration and congestion management. A comprehensive management for core health metrics will also be provided. Clinicians review and confirm recommendations before they are communicated to patients.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Usual Care with guideline-recommended outpatient follow-up. No platform-based risk stratification or decision support is provided. |
| Digital Remote Management | Experimental | Participants will use a digital remote-management platform to report symptoms and key physiologic variables (e.g., blood pressure and body weight). The platform applies a predefined risk-stratification algorithm and provides clinician-facing decision support for GDMT titration and congestion management. A comprehensive management for core health metrics will also be provided. Clinicians review and confirm recommendations before they are communicated to patients. Receives: Other: Digital Remote Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hear failure GDMT score (ΔGDMT) from baseline to 3 months
The Guideline-Directed Medical Therapy (GDMT) Score is a modified heart-failure pharmacotherapy score based on five medication classes:
- angiotensin-converting enzyme inhibitors or angiotensin receptor blockers (ACEi/ARB),
- angiotensin receptor-neprilysin inhibitor (ARNI),
- beta-blockers (BB),
- mineralocorticoid receptor antagonists (MRA), and
- sodium-glucose cotransporter-2 inhibitors (SGLT2i).
Dosing levels are scored as follows:
- ACEi/ARB: 0 = none; 0 = <50% target dose; 1 = ≥50% target dose.
- ARNI: 0 = none; 1 = <50% target dose; 2 = ≥50% target dose.
- Beta-blocker: 0 = none; 1 = <50% target dose; 2 = ≥50% target dose.
- MRA: 0 = none; 1 = <50% target dose; 2 = ≥50% target dose.
- SGLT2 inhibitor: 0 = none; 2 = therapeutic dose (no low-dose category). The total GDMT Score ranges from 0 to 9, with higher scores indicating more complete, optimized, and guideline-concordant HF medical therapy.
Measured: 3 months after randomization
Secondary outcomes (10)
Heart failure hospitalization
Measured: 3 months after randomization
Cardiovascular hospitalization
Measured: 3 months after randomization
Cardiovascular mortality
Measured: 3 months after randomization
All-cause mortality
Measured: 3 months after randomization
Change in NT-proBNP from baseline
Measured: 3 months after randomization
Change in functional capacity
6-minute walk distance
Measured: 3 months after randomization
Change in KCCQ score
The Kansas City Cardiomyopathy Questionnaire-23 (KCCQ-23) is a 23-item patient-reported outcome measure of heart-failure-specific health status (symptoms, physical and social limitations, and quality of life). Each item is rated on a 5-point Likert scale (1 = extremely limited to 5 = not at all limited; response options such as "limited for other reasons or did not do this activity" are treated as missing). Domain scores are transformed to a 0-100 scale, and the overall summary score ranges from 0 to 100, with higher scores indicating better health status and fewer symptoms.
Measured: 3 months after randomization
Change in EQ-5D-5L score
The EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) describes health status in five domains (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each rated on 5 levels (1 = no problems to 5 = extreme problems). A utility index score is derived using the Chinese value set, with values ranging approximately from -0.281 to 1.000, and an accompanying visual analogue scale (VAS) score ranging from 0 to 100, where higher scores on both the index and the VAS indicate better health status.
Measured: 3 months after randomization
Proportion of patients with heart failure with improved ejection fraction (HFimpEF, LVEF increased by 10% to >40%)
Measured: 3 months after randomization
Emergency department visits and hospitalizations related to evidence-based medical therapies for HFrEF including symptomatic hypotension, hyperkalemia, and angioedema
Measured: 3 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start26 Feb 2026
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Reduced Ejection FractionStudies of the same condition, open and under way.
- More trials run by Beijing Anzhen HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 252 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The First Hospital of Jilin University, Second Affiliated Hospital of Nanchang University
- Responsible party
- Principal investigator, Chang sheng Ma, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07352891
- Sponsor's protocol ID
- KS2025289
- Acronym
- DigiCare-HFrEF
- Status last verified
- Apr 2026
- First submitted
- 31 Dec 2025
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07352891
- Acronym / sponsor ID
- DigiCare-HFrEF / KS2025289
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 252 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Collaborators
- The First Hospital of Jilin University, Second Affiliated Hospital of Nanchang University
- Study start
- 26 Feb 2026 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 20 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Heart failure with reduced ejection fraction (HFrEF) remains associated with high rates of early post-discharge events. In routine practice, timely optimisation of guideline-directed medical therapy (GDMT) and early recognition of haemodynamic deterioration are frequently limited by infrequent follow-up, delayed access to physiologic data, and variability in patient self-management.
DigiCare-HFrEF will enroll hospitalised patients with confirmed HFrEF and randomise them to either:
- digital remote management based on an integrated platform that supports daily symptom and vital-sign reporting, algorithm-driven risk stratification, and clinician-reviewed decision support for GDMT titration and congestion management, plus standard guideline-based care; or
- usual care with medical therapy and regular follow-up.
Randomisation will be performed through a central web-based system with stratification by participating centre and age (≤65 vs >65 years). Given the nature of the intervention, treatment allocation is open label; however, outcome assessment and event adjudication will be performed by independent personnel blinded to treatment assignment. Participants will be followed with standardised remote assessments at 1 months and face-to-face visits at 3 months. The trial will test whether a closed-loop digital care pathway-continuous monitoring, rapid risk-informed evaluation, and standardised responses with clinician oversight-reduces major clinical events and improves GDMT optimisation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Usual Care with guideline-recommended outpatient follow-up. No platform-based risk stratification or decision support is provided. |
| Digital Remote Management | Experimental | Other: Digital Remote ManagementParticipants will use a digital remote-management platform to report symptoms and key physiologic variables (e.g., blood pressure and body weight). The platform applies a predefined risk-stratification algorithm and provides clinician-facing decision support for GDMT titration and congestion management. A comprehensive management for core health metrics will also be provided. Clinicians review and confirm recommendations before they are communicated to patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital Remote ManagementParticipants will use a digital remote-management platform to report symptoms and key physiologic variables (e.g., blood pressure and body weight). The platform applies a predefined risk-stratification algorithm and provides clinician-facing decision support for GDMT titration and congestion management. A comprehensive management for core health metrics will also be provided. Clinicians review and confirm recommendations before they are communicated to patients. | Other | Digital Remote Management |
Primary outcome
Change in hear failure GDMT score (ΔGDMT) from baseline to 3 months
Time frame: 3 months after randomization
The Guideline-Directed Medical Therapy (GDMT) Score is a modified heart-failure pharmacotherapy score based on five medication classes: 1. angiotensin-converting enzyme inhibitors or angiotensin receptor blockers (ACEi/ARB), 2. angiotensin receptor-neprilysin inhibitor (ARNI), 3. beta-blockers (BB), 4. mineralocorticoid receptor antagonists (MRA), and 5. sodium-glucose cotransporter-2 inhibitors (SGLT2i). Dosing levels are scored as follows: * ACEi/ARB: 0 = none; 0 = <50% target dose; 1 = ≥50% target dose. * ARNI: 0 = none; 1 = <50% target dose; 2 = ≥50% target dose. * Beta-blocker: 0 = none; 1 = <50% target dose; 2 = ≥50% target dose. * MRA: 0 = none; 1 = <50% target dose; 2 = ≥50% target dose. * SGLT2 inhibitor: 0 = none; 2 = therapeutic dose (no low-dose category). The total GDMT Score ranges from 0 to 9, with higher scores indicating more complete, optimized, and guideline-concordant HF medical therapy.
10 secondary outcomes
Heart failure hospitalization
Time frame: 3 months after randomization
Cardiovascular hospitalization
Time frame: 3 months after randomization
Cardiovascular mortality
Time frame: 3 months after randomization
All-cause mortality
Time frame: 3 months after randomization
Change in NT-proBNP from baseline
Time frame: 3 months after randomization
Change in functional capacity
Time frame: 3 months after randomization
Change in KCCQ score
Time frame: 3 months after randomization
Change in EQ-5D-5L score
Time frame: 3 months after randomization
Proportion of patients with heart failure with improved ejection fraction (HFimpEF, LVEF increased by 10% to >40%)
Time frame: 3 months after randomization
Emergency department visits and hospitalizations related to evidence-based medical therapies for HFrEF including symptomatic hypotension, hyperkalemia, and angioedema
Time frame: 3 months after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Heart Failure With Reduced Ejection Fraction
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
Recruiting
Endovascular Ablation of the Right Greater Splanchnic Nerve in Subjects With Reduced Ejection Fraction
Heart Failure With Reduced Ejection Fraction (HFrEF)
RecruitingObservational study
Descriptive Study of Circulating Gene or Protein Inflammatory Biomarkers and Bioimpedance Parameters in a Population of Patients Hospitalized for Decompensated Heart Failure With Preserved or Mildly Reduced Cardiac Function
Inflammation Biomarkers, Heart Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Remote Management in people with Heart Failure With Reduced Ejection Fraction, run by Beijing Anzhen Hospital at 6 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact DigiCare-HFrEF Coordinating Center (chshma@vip.sina.com, chshma@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in hear failure GDMT score (ΔGDMT) from baseline to 3 months (time frame: 3 months after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.