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)

NCT07352891 | Recruiting DMC

• 1 other identifier: KS2025289
• Study Type: interventional
• Target: 252
• Locations: 1 country
• Sites: 6

Brief 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) 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).

Conditions

Heart Failure With Reduced Ejection Fraction

Outcome Measures

Primary Outcomes (1)

• 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: 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 Outcomes (10)

• Heart failure hospitalization

  3 months after randomization

• Cardiovascular hospitalization

  3 months after randomization

• Cardiovascular mortality

  3 months after randomization

• All-cause mortality

  3 months after randomization

• Change in NT-proBNP from baseline

  3 months after randomization

Study Arms (2)

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.

Other: Digital Remote Management

Interventions

Digital Remote Management OTHER

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.

Digital Remote Management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged ≥18 years.
• Hospitalised at a secondary or tertiary hospital with established heart failure care capacity.
• 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.

You may not qualify 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).
• 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.

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead
• The First Hospital of Jilin University: collaborator
• Second Affiliated Hospital of Nanchang University: collaborator

Study Sites (6)

Beijing Anzhen Hospital, Capital Medical University, Beijing, China

Beijing, China

RECRUITING

Beijing Tongren Hospital, Capital Medical University, Beijing, China

Beijing, China

RECRUITING

The First Affiliated Hospital of Dalian Medical University, Dalian, China

Dalian, China

RECRUITING

The First Hospital of Jilin University, Changchun, China

Jilin, China

RECRUITING

The Second Affiliated Hospital of Nanchang University, Nanchang, China

Nanchang, China

NOT YET RECRUITING

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China

Shanghai, China

NOT YET RECRUITING

Central Study Contacts

DigiCare-HFrEF Coordinating Center

CONTACT

chshma@vip.sina.com; chshma@vip.sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of cardiology department

Study Record Dates

• First Submitted: December 31, 2025
• First Posted: January 20, 2026
• Study Start: February 26, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (6)