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Идёт набор NCT07247032

Heart Failure Management for Patient With CIED Remotely Monitored

Без фазы С лечением Heart Failure Heart Failure NYHA Class II Heart Failure NYHA Class III Heart Failure With Reduced Ejection Fraction (HFrEF)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: SmartSignalHF, HF RM standard of care.
Кому может быть актуально
Состояния в реестре: Heart Failure, Heart Failure NYHA Class II, Heart Failure NYHA Class III, Heart Failure With Reduced Ejection Fraction (HFrEF). Базовые параметры: 18 лет — 85 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
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Официальное название

Prospective Real World Heart Failure Management for Patient With CIED Remotely Monitored

Обзор

This randomized, controlled, open-label, parallel, multicenter clinical study evaluates the efficacy of SmartSignalHF compared with heart failure (HF) remote monitoring (RM) standard of care in implanted patients with heart failure. The primary objective is to determine whether SmartSignalHF reduces all-cause mortality and HF hospitalizations at 12 months.

Подробное описание

SmartSignalHF is a novel digital health solution designed to support clinical decision-making by continuously analyzing Cardiac Implantable Electronic Devices (CIED) and patient data and providing actionable alerts to healthcare teams. By integrating this digital solution into the remote monitoring of HF patients, the study aims to enhance early detection of decompensation events and optimize therapeutic treatments.

Eligible patients implanted with an Implantable Cardioverter Defibrillator (ICD) or a Cardiac Resynchronization Therapy Defibrillator (CRT-D) and diagnosed with chronic heart failure will be randomized in a 1:1 ratio to either SmartSignalHF remote monitoring solution or standard HF remote monitoring solution.

The primary endpoint is a composite of all-cause mortality and HF hospitalizations within 12 months after randomization. Secondary endpoints include individual components of the primary endpoint, quality-of-life measures, and adherence to guideline-directed medical therapy (GDMT).

Вмешательства

  • Устройство SmartSignalHF
    SmartSignalHF; a solution aiming to predict episodes of cardiac decompensation in patients implanted with an ICD or CRT-D
  • Устройство HF RM standard of care
    HF RM standard of care defined in the country (France or Germany)

Первичные конечные точки

  • Composite measure of all-cause mortality and HF hospitalizations [Срок оценки: From enrollment to the end of follow-up at 12 months]
Вторичные конечные точки (12)
  • All-cause mortality [Срок оценки: From enrollment to the end of follow-up at 12 months]
  • HF mortality [Срок оценки: From enrollment to the end of follow-up at 12 months]
  • HF hospitalizations [Срок оценки: From enrollment to the end of follow-up at 12 months]
  • HF readmissions [Срок оценки: From enrollment to the end of follow-up at 12 months]
  • HF outpatient visits [Срок оценки: From enrollment to the end of follow-up at 12 months]
  • All cause hospitalizations [Срок оценки: From enrollment to the end of follow-up at 12 months]
  • HF hospitalization duration [Срок оценки: From enrollment to the end of follow-up at 12 months]
  • Proportion of patients without contraindications receiving 4- drug GDMT [Срок оценки: At 12 months]
  • Proportion of patients achieving ≥ 50% target doses or maximum tolerated doses for each drug class [Срок оценки: At 12 months]
  • Proportion of patients achieving 100% target doses or maximum tolerated doses for each drug class [Срок оценки: At 12 months]
  • Minnesota Living with Heart Failure Questionnaire (MLHFQ) total score [Срок оценки: At baseline and at 12 months]
  • Rate of patients who completed the study follow-up [Срок оценки: At 12 months]

Критерии участия

Критерии включения

  • Patient aged 18-85
  • Patient diagnosed with a New York Heart Association (NYHA) class II or III
  • Patients with left ventricular ejection fraction ≼ 40 %
  • Patient implanted with an ICD or CRT-D (BiV and/or LBBA pacing) since at least 30 days and compatible with SignalHF (Biotronik, Boston Scientific and Medtronic)
  • Non-activation of others HF multisensor algorithms
  • Patient remote monitored on Implicity CIED platform
  • Patient with a documented diagnosis of heart failure, eligible to reimbursement in France or Germany for HF remote monitoring
  • Patient is willing to be remotely monitored for heart failure
  • HF treated according to European Society of Cardiology (ESC) guidelines

Критерии исключения

  • Patients undergoing or awaiting heart transplant or left ventricular assist device (LVAD) procedures
  • Patients with a life expectancy of less than 12 months
  • Patients enrolled in concurrent clinical studies
  • Patients with a history of non-compliance with medical care or inability to comply with the study protocol
  • Patients already receiving remote monitoring for heart failure
  • Pregnant or breastfeeding women
  • Subjects under legal protection

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
Открытое
Основная цель
Профилактика

Центры проведения

Франция · 1 центр
  • Implicity — Paris

Идентификаторы

NCT: NCT07247032 · 2025-A01507-42

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗