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) (DigiCare-HFrEF)

April 21, 2026 updated by: Chang sheng Ma, Beijing Anzhen Hospital

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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:

  1. 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
  2. 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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
252

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: DigiCare-HFrEF Coordinating Center
  • Phone Number: chshma@vip.sina.com
  • Email: chshma@vip.sina.com

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Beijing Anzhen Hospital, Capital Medical University, Beijing, China
      • Beijing, China
        • Recruiting
        • Beijing Tongren Hospital, Capital Medical University, Beijing, China
      • Dalian, China
        • Recruiting
        • The First Affiliated Hospital of Dalian Medical University, Dalian, China
      • Jilin, China
        • Recruiting
        • The First Hospital of Jilin University, Changchun, China
      • Nanchang, China
        • Not yet recruiting
        • The Second Affiliated Hospital of Nanchang University, Nanchang, China
      • Shanghai, China
        • Not yet recruiting
        • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Usual Care
Usual Care with guideline-recommended outpatient follow-up. No platform-based risk stratification or decision support is provided.
Experimental: Digital Remote Management
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.
Other: Digital Remote Management
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
3 months after randomization

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
All-cause mortality
Time Frame: 3 months after randomization
3 months after randomization
Heart failure hospitalization
Time Frame: 3 months after randomization
3 months after randomization
Cardiovascular hospitalization
Time Frame: 3 months after randomization
3 months after randomization
Cardiovascular mortality
Time Frame: 3 months after randomization
3 months after randomization
Change in NT-proBNP from baseline
Time Frame: 3 months after randomization
3 months after randomization
Change in functional capacity
Time Frame: 3 months after randomization
6-minute walk distance
3 months after randomization
Change in KCCQ score
Time Frame: 3 months after randomization
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.
3 months after randomization
Change in EQ-5D-5L score
Time Frame: 3 months after randomization
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.
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
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
3 months after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beijing Anzhen Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The First Hospital of Jilin University
Second Affiliated Hospital of Nanchang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 26, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 31, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 20, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KS2025289

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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