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)

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

Overview

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:

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.

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.

Primary outcome measures

• Change in hear failure GDMT score (ΔGDMT) from baseline to 3 months [Time frame: 3 months after randomization]

Secondary outcome measures (10)

• 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]

Eligibility criteria

Inclusion 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 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

China · 6 centers

• Beijing Anzhen Hospital, Capital Medical University, Beijing, China — Beijing
• Beijing Tongren Hospital, Capital Medical University, Beijing, China — Beijing
• The First Affiliated Hospital of Dalian Medical University, Dalian, China — Dalian
• The First Hospital of Jilin University, Changchun, China — Jilin City
• The Second Affiliated Hospital of Nanchang University, Nanchang, China — Nanchang
• Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China — Shanghai

Identifiers

NCT: NCT07352891 · KS2025289

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗