Recruiting

NCT Number: NCT07174141

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

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.

Recruiting

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Dijon Bourgogne

Dijon, France

Location status: Recruiting

Location contact

Romain DIDIER

CONTACT

[email protected]

0380293031

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ophthalmological examination

Other

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

Blood sample

Biological

Collection of a 2 mL blood sample at inclusion

Primary outcomes

Number of participants with a diagnosis of new-onset high blood pressure or worsening of pre-existing hypertension

Time frame: 12 months after initiation of treatment with second-generation Bruton's tyrosine kinase inhibitors in hematology

Study contacts

Contact information is provided by the study sponsor or research team.

Romain DIDIER

CONTACT

[email protected]

0380293031

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon