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

Recruiting now

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

In brief

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.

Key facts

Study ID: NCT07174141
Run by: Centre Hospitalier Universitaire Dijon
People needed: 100
Starts: 2025-11-28
Expected to finish: 2028-11-01
Last updated by the study team: 2025-12-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

CHU Dijon Bourgogne — Dijon, France (enrolling)

Full record on ClinicalTrials.gov

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