Overview
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.
Description
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.
Eligibility
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
