HeartLogic™ Evaluation for Remote Monitoring vs. Office-based Follow-up in Patients With Heart Failure.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 578
- 试验地点
- 15
- 主要终点
- Proportion of patients who are alive with no unscheduled hospitalization for heart failure and no deterioration in quality of life.
研究概览
简要总结
This randomized, multicenter clinical trial will evaluate whether remote management guided by the HeartLogic™ algorithm improves outcomes compared with traditional face-to-face follow-up in adult patients with heart failure recently implanted with a HeartLogic™-enabled ICD or CRT-D device. The primary objective is to determine whether this strategy reduces, at 12 months, the proportion of patients with death, unscheduled hospitalization for heart failure, or deterioration in quality of life. Secondary objectives include assessment of hospitalization, mortality, quality of life, safety, and cost-effectiveness.
详细描述
Heart failure is associated with recurrent decompensation, frequent hospitalization, impaired quality of life, and substantial healthcare costs. HeartLogic™ is a multisensor algorithm available in compatible Boston Scientific ICD and CRT-D devices that integrates device-derived parameters, including heart sounds, thoracic impedance, respiratory rate, heart rate, and activity level, to identify early signs of worsening heart failure.
Although previous studies have shown that HeartLogic™ alerts may precede heart failure events, the benefit of a structured management strategy based on these alerts has not been established in a randomized trial. The HERO study is a prospective, multicenter, open-label, randomized, parallel-group trial designed to evaluate this strategy in routine practice.
Participants will be randomized to either HeartLogic™-guided remote management or conventional face-to-face follow-up without use of HeartLogic™ alerts. In the intervention group, alerts transmitted through the Latitude™ platform may trigger patient contact, clinical assessment, and therapeutic adjustment according to a predefined management pathway and local practice. In both groups, patient-reported outcomes and clinical events will be collected during 12 months of follow-up.
The study also includes a health economic evaluation to compare the cost-effectiveness of the 2 management strategies.
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
- •Patients aged ≥18 years old;
- •Patients implanted with a cardiac defibrillator for less than 6 months, with or without resynchronization, enabling the HeartLogic™ algorithm;
- •Patients with a history of HF (left ventricular ejection fraction ≤40%; or at least one episode of clinical HF with NT-proBNP blood concentration ≥450 ng/L);
- •Patients with New York Heart Association Class II or III HF;
- •Patient able to comply with the protocol, including Latitude™ transmissions (including adequate connectivity), and study visits.
- •Patients with compulsory health insurance
排除标准
- •Patients not consenting and non-compliant with remote care directions.
- •Patients with invasive remote HF monitoring device (such as CardioMems);
- •Patients with a concomitant HF device other than cardiac resynchronization, such as a ventricular assist devices or cardiac contractility modulation devices;
- •Patients on heart transplant list, or patients with a heart transplant;
- •Patients with a glomerular filtration rate <30 ml/min/m2;
- •Participation to a concomitant study evaluating management of HF decompensation, or diuretic titration.
- •Patients enable to consent.
- •Patients receiving State Medical Aid (Aide Médicale d'Etat).
- •Pregnant or breastfeeding women.
- •Persons benefiting from a reinforced protection, namely minors, persons deprived of liberty by a judicial or administrative decision, adults under legal protection, and finally patients in emergency situations
研究组 & 干预措施
Conventional face-to-face HF management (no monitoring of HeartLogic alerts)
The control group is treated with a usual follow-up. Current guidelines recommend follow-up at intervals no longer than 6 months. They will be monitored at baseline, 6 and 12 months after inclusion.
干预措施: Traditional follow up (Other)
Remote HF management guided with the HeartLogic™ algorithm.
After enrolment, patients of the intervention arm will be remotely followed up based on an alert-driven strategy by the local research coordinator. In case of index value ≥16, diuretics should be increased during 4 to 5 days, or HF guidelines directed medication therapy will be up titrated.
干预措施: Alert-guided remote follow-up (Other)
结局指标
主要结局
Proportion of patients who are alive with no unscheduled hospitalization for heart failure and no deterioration in quality of life.
时间窗: 12-month follow-up
The primary outcome is the proportion of patients, at 12 months, who are alive with no unscheduled hospitalization for heart failure and no deterioration in quality of life, defined as a reduction of 5 points or more in the Kansas City Cardiomyopathy Questionnaire (KCCQ).
次要结局
- Total number of outpatient clinic consultations(12-month follow-up)
- Win ratio(12-month follow-up)
- Cumulative incidence of unscheduled hospitalization for heart failure(12-month follow-up)
- Cumulative incidence of heart failure-related death(12-month follow-up)
- Cumulative incidence of cardiovascular death(12-month follow-up)
- Number of all-cause death(12-month follow-up)
- Change in quality of life(Change between baseline and 12 months of follow-up)
- The efficiency of patient care in terms of cost-utility(12-month follow-up)
- Total number of hospitalization(12-month follow-up)
- Total hospitalization duration(12-month follow-up)
- Proportion of patients with a safety criteria(12-month follow-up)