HeartLogic™ in Patients With Heart Failure.

Официальное название

HeartLogic™ Evaluation for Remote Monitoring vs. Office-based Follow-up in Patients With Heart Failure.

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Alert-guided remote follow-up
  Participants assigned to this intervention will receive alert-guided remote follow-up for heart failure. Device-generated alerts suggestive of worsening heart failure will be reviewed by the study team through the remote monitoring platform. When an alert occurs, patients may be contacted for symptom assessment and clinical evaluation, and treatment may be adjusted preemptively according to a predefined care pathway and local clinical practice.
• Другое Traditional follow up
  Patients will be monitored every 6 months as recommended by the guidelines

Первичные конечные точки

• Proportion of patients who are alive with no unscheduled hospitalization for heart failure and no deterioration in quality of life. [Срок оценки: 12-month follow-up]

Вторичные конечные точки (11)

• Win ratio [Срок оценки: 12-month follow-up]
• Cumulative incidence of unscheduled hospitalization for heart failure [Срок оценки: 12-month follow-up]
• Cumulative incidence of heart failure-related death [Срок оценки: 12-month follow-up]
• Cumulative incidence of cardiovascular death [Срок оценки: 12-month follow-up]
• Number of all-cause death [Срок оценки: 12-month follow-up]
• Change in quality of life [Срок оценки: Change between baseline and 12 months of follow-up]
• The efficiency of patient care in terms of cost-utility [Срок оценки: 12-month follow-up]
• Total number of hospitalization [Срок оценки: 12-month follow-up]
• Total hospitalization duration [Срок оценки: 12-month follow-up]
• Total number of outpatient clinic consultations [Срок оценки: 12-month follow-up]
• Proportion of patients with a safety criteria [Срок оценки: 12-month follow-up]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Франция · 15 центров

• University hospital of Amiens — Amiens
• University hospital of Brest — Brest
• University hospital of Caen — Caen
• University hospital of Grenoble — Grenoble
• University hospital of Lille — Lille
• La Timone University hospital — Marseille
• Hopital du Confluent — Nantes
• University hospital of Nantes — Nantes
• … и ещё 7 центров

Публикации

• Garcia R, Gras D, Mansourati J, Defaye P, Bisson A, Boveda S, Gandjbakhch E, Gras M, Gueffet JP, Himbert C, Jacon P, Khattar P, Lequeux B, Li A, Mansourati V, Minois D, Marijon E, Pierre B, Probst V, Degand B; HeartLogic France Cohort Study Investigators. Pre-emptive treatment of heart failure exacerbations in patients managed with the HeartLogic algorithm. ESC Heart Fail. 2024 Apr;11(2):1228-1235 PMID 38234123
• Garcia R, Gras D, Mansourati J, Defaye P, Bisson A, Boveda S, Durocher L, Gandjbakhch E, Gras M, Gueffet JP, Himbert C, Jacon P, Khattar P, Lequeux B, Li A, Mansourati V, Minois D, Marijon E, Pierre B, Ragot S, Probst V, Degand B. Impact and safety of remote monitoring of heart failure patients managed with the HeartLogic algorithm: the HeartLogic France Cohort Study. Eur Heart J Digit Health. 202 PMID 41624570

Идентификаторы

NCT: NCT07544771 · HERO

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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