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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 252
- 试验地点
- 6
- 主要终点
- Change in hear failure GDMT score (ΔGDMT) from baseline to 3 months
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Usual Care
Usual Care with guideline-recommended outpatient follow-up. No platform-based risk stratification or decision support is provided.
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.
干预措施: Digital Remote Management (Other)
结局指标
主要结局
Change in hear failure GDMT score (ΔGDMT) from baseline to 3 months
时间窗: 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.
次要结局
- Change in functional capacity(3 months after randomization)
- 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)
- Change in KCCQ score(3 months after randomization)
- Change in EQ-5D-5L score(3 months after randomization)
- Proportion of patients with heart failure with improved ejection fraction (HFimpEF, LVEF increased by 10% to >40%)(3 months after randomization)
- Emergency department visits and hospitalizations related to evidence-based medical therapies for HFrEF including symptomatic hypotension, hyperkalemia, and angioedema(3 months after randomization)
研究者
Chang sheng Ma
Director of cardiology department
Beijing Anzhen Hospital