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Clinical Trials in France / NCT07174141
Recruiting Observational

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

NCT07174141 · tracked via the Priya Life Science France tracker
Sponsor
Centre Hospitalier Universitaire Dijon
Phase
Observational
Started
2025-11-28
Last updated
2025-12-04

Condition(s) studied

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

Investigational drug(s) / intervention(s)

Ophthalmological examinationBlood sample →

Ophthalmological examination: at inclusion, at 3 months and 6 months; OCT-A retina

Blood sample: Collection of a 2 mL blood sample at inclusion

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * 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

Primary outcome measure(s)

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

Trial sites (1)

FacilityCityRegionStatus
CHU Dijon Bourgogne Dijon France Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07174141 on ClinicalTrials.gov ↗ ← All trials in France