HeartLogic™ in Patients With Heart Failure.

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.

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