NCT07174141

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Centre Hospitalier Universitaire Dijon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
OTHER	Ophthalmological examination	at inclusion, at 3 months and 6 months; OCT-A retina
BIOLOGICAL	Blood sample	Collection of a 2 mL blood sample at inclusion

Timeline

• Start date: 2025-11-28
• Primary completion: 2028-11-01
• Completion: 2028-11-01
• First posted: 2025-09-15
• Last updated: 2025-12-04

Locations

1 site across 1 country: France