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Идёт набор NCT07174141

Innovative Biomarkers of Cardiovascular Complications Associated With Second-generation Bruton Tyrosine Kinase Inhibitor Treatments: a Single-center Cohort Study

— Наблюдательное Treatment With Second-generation Bruton's Tyrosine Kinase Inhibitors (Acalabrutinib, Zanubrutinib)

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: Ophthalmological examination, Blood sample.
Кому может быть актуально
Состояния в реестре: Treatment With Second-generation Bruton's Tyrosine Kinase Inhibitors (Acalabrutinib, Zanubrutinib). 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
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Обзор

Second-generation Bruton's tyrosine kinase inhibitors (BTKIs) (zanubrutinib, acalabrutinib) are recently discovered oral targeted therapies used to treat hematological disorders such as chronic lymphocytic leukemia, mantle cell lymphoma, non-Hodgkin's lymphoma, and Waldenström's macroglobulinemia. These treatments significantly increase survival rates for these diseases, but over the years, we have observed the emergence of cardiovascular adverse effects such as cardiac arrhythmia and high blood pressure, the type and frequency of which differ from those of first-generation drugs such as ibrutinib. The frequency of these cardiovascular events remains poorly understood, as do the risk factors for developing these complications. The aim of this study is to determine the exact incidence of cardiac arrhythmia and high blood pressure in patients receiving second-generation IBTK and to identify risk factors that can predict these complications through close, specialized monitoring. Ultimately, this will make it possible to better target patients at highest risk of developing cardiovascular complications and offer them appropriate follow-up care. This is a single-center, prospective, observational study conducted at the Dijon Bourgogne University Hospital. The required number of subjects is 100 patients. The total follow-up period for each patient is one year.

Вмешательства

  • Другое Ophthalmological examination
    at inclusion, at 3 months and 6 months; OCT-A retina
  • Биопрепарат Blood sample
    Collection of a 2 mL blood sample at inclusion

Первичные конечные точки

  • Number of participants with a diagnosis of new-onset high blood pressure or worsening of pre-existing hypertension [Срок оценки: 12 months after initiation of treatment with second-generation Bruton's tyrosine kinase inhibitors in hematology]

Критерии участия

Критерии включения

  • Patients eligible for treatment with second-generation Bruton's tyrosine kinase inhibitors in hematology (acalabrutinib, zanubrutinib)
  • Patients aged 18 years and older
  • Patients who have given their free and informed written consent to participate in this study after receiving information (or the patient's representative if the patient is unable to express consent themselves).
  • Patients with a life expectancy estimated by the hematologist in charge of the patient to be greater than one year

Критерии исключения

  • Persons not affiliated with or not covered by a social security system
  • Patients subject to legal protection measures (guardianship, trusteeship)
  • Patients subject to judicial protection measures
  • Pregnant women, women in labor, or breastfeeding women
  • Prior treatment with Bruton's tyrosine kinase inhibitors (ibrutinib, acalabrutinib, zanubrutinib)
  • Follow-up planned at another center
  • History of atrial fibrillation
  • Uncontrolled hypertension

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Франция · 1 центр
  • CHU Dijon Bourgogne — Dijon

Идентификаторы

NCT: NCT07174141 · ROBERT_AOI_2022

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗