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Набор скоро начнётся NCT06029166

Subcutaneous Cardiac Monitoring of Patients With BTK Inhibitors

Без фазы С лечением Atrial Fibrillation

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: Insertable subcutaneous cardiac monitor (BIOMONITOR IIIm®, Biotronik®).
Кому может быть актуально
Состояния в реестре: Atrial Fibrillation. Базовые параметры: от 18 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Electrocardiographic Changes and Rhythm Disorders Associated With BTK Inhibitors Exposure Using an Insertable Subcutaneous Cardiac Monitor: a Multicenter Cardio-Oncology Prospective Cohort

Обзор

The goal of this clinical trial is to screen all types of electrocardiographic changes and rhythm disorders in adult patients with a hematologic malignancy requiring a treatment by Bruton's tyrosine kinase (BTK) inhibitor (ibrutinib, acalabrutinib, zanubrutinib) using an insertable subcutaneous cardiac monitor (ISCM) and occurring from inclusion and within 12 months. This study consists of the implantation of an ISCM at inclusion and before BTK inhibitor initiation. Then patients will have medical visits every 3 months (+/- 7 days) during 12 months and a continuous cardiac telemonitoring using the ISCM.

Вмешательства

  • Устройство Insertable subcutaneous cardiac monitor (BIOMONITOR IIIm®, Biotronik®)
    Implantation of a subcutaneous cardiac monitor (BIOMONITOR IIIm®, Biotronik®) before beginning the Bruton's tyrosine kinase inhibitor treatment.

Первичные конечные точки

  • Occurrence of any electrocardiographic changes and/or rhythm disorders from first BTK inhibitors prescription to 12 months of follow-up, symptomatic or not, detected on 12-lead ECG and/or on ISCM. [Срок оценки: 3, 6, 9 and 12 months after introduction of ibrutinib therapy (+/- 7 days)]
Вторичные конечные точки (9)
  • Electrocardiographic intervals (PR, QRS, QT) measurements on both 12-lead ECG and ISCM at baseline and with BTK inhibitors exposure. [Срок оценки: 3, 6, 9 and 12 months after introduction of ibrutinib therapy (+/- 7 days)]
  • The occurrence of bleeding events from inclusion and within 12 months. [Срок оценки: 3, 6, 9 and 12 months after introduction of ibrutinib therapy (+/- 7 days)]
  • Correlation between IRAF and multiple demographic, clinical, cardiac imaging (morphological data) and serum cardiac biomarkers. [Срок оценки: 3, 6, 9 and 12 months after introduction of ibrutinib therapy (+/- 7 days)]
  • IRAF management. [Срок оценки: 3, 6, 9 and 12 months after introduction of ibrutinib therapy (+/- 7 days)]
  • Progression-free survival of patients treated by BTK inhibitors according to the presence of IRAF. [Срок оценки: 3, 6, 9 and 12 months after introduction of ibrutinib therapy (+/- 7 days)]
  • Correlation between QT/QTc measurements performed by ISCM (BIOMONITOR IIIm®, Biotronik®) and a QT expert on 12-leads ECG. [Срок оценки: 3, 6, 9 and 12 months after introduction of ibrutinib therapy (+/- 7 days)]
  • Daily body temperature monitoring with the ISCM (BIOMONITOR IIIm®, Biotronik®) temperature sensor and will be compared with conventional body temperature measurements performed during follow-up visits. [Срок оценки: 3, 6, 9 and 12 months after introduction of ibrutinib therapy (+/- 7 days)]
  • Constitute a plasmatic biobank for futures ancillary studies. [Срок оценки: 3, 6, 9 and 12 months after introduction of ibrutinib therapy (+/- 7 days)]
  • The need for ISCM (BIOMONITOR IIIm®, Biotronik®) remove within the 12-months follow-up. [Срок оценки: 3, 6, 9 and 12 months after introduction of ibrutinib therapy (+/- 7 days)]

Критерии участия

Критерии включения

  • Adult patients,
  • Definite diagnosis of hematologic malignancy requiring a BTK inhibition with ibrutinib, acalabrutinib or zanubrutinib,
  • Expected BTK inhibitor duration estimated to be at least 12 months,
  • Sinus rhythm at enrolment,
  • Willing to sign patient consent form and to comply with scheduled visits, as outlined in the protocol

Критерии исключения

  • Age < 18 years old,
  • Adults with protective measures (curatorship or tutorship) and vulnerable patients,
  • Pregnant or nursing women,
  • Permanent atrial fibrillation or long-standing persistent atrial fibrillation as defined by the European Society of Cardiology guidelines,
  • Atrial fibrillation on the electrocardiogram at the inclusion visit,
  • Previous left atrial ablation or previous maze or maze-like surgery,
  • Indication for or patients with a pacemaker or implantable cardioverter-defibrillator at baseline,
  • Untreated hyperthyroidism,
  • Uncorrected kaliaemia disorders at the inclusion visit,
  • Hemoglobin < 8 g/L at the inclusion visit,
  • Thrombopenia < 50,000/mm3 at the inclusion visit,
  • Active bleeding,
  • Myocardial infarction < 1 month,
  • Surgery < 1 month,
  • Mechanical heart valve,
  • Valvular heart disease requiring surgery,
  • Inability to follow the required procedures of the clinical investigation plan,
  • No signature of patient consent form.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Диагностика

Центры проведения

Франция · 1 центр
  • Caen University Hospital, Department of Pharmacology — Caen

Идентификаторы

NCT: NCT06029166 · 22-0252

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗