Innovative Biomarkers of Cardiovascular Complications Associated With Second-generation Bruton Tyrosine Kinase Inhibitor Treatments: a Single-center Cohort Study
NCT ID: NCT07174141
Last Updated: 2025-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2025-11-28
2028-11-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients
Patients eligible for treatment with second-generation Bruton's tyrosine kinase inhibitors in hematology (acalabrutinib, zanubrutinib)
Ophthalmological examination
at inclusion, at 3 months and 6 months; OCT-A retina
Blood sample
Collection of a 2 mL blood sample at inclusion
Interventions
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Ophthalmological examination
at inclusion, at 3 months and 6 months; OCT-A retina
Blood sample
Collection of a 2 mL blood sample at inclusion
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire Dijon
OTHER
Responsible Party
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Locations
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CHU Dijon Bourgogne
Dijon, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ROBERT_AOI_2022
Identifier Type: -
Identifier Source: org_study_id
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