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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)

NCT07352891 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 252

Last updated 2026-04-24

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • The First Hospital of Jilin University

    collaborator OTHER

  • Second Affiliated Hospital of Nanchang University

    collaborator OTHER

  • Beijing Anzhen Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-26
Primary Completion
2026-07-31
Completion
2026-07-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07352891 on ClinicalTrials.gov