NCT07174141 Innovative Biomarkers of Cardiovascular Complications Associated With Second-generation Bruton Tyrosine Kinase Inhibitor Treatments: a Single-center Cohort Study
| NCT ID | NCT07174141 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire Dijon |
| Condition | Treatment With Second-generation Bruton's Tyrosine Kinase Inhibitors (Acalabrutinib, Zanubrutinib) |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-11-28 |
| Primary Completion | 2028-11 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2025-11-28 with a primary completion date of 2028-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07174141 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Treatment With Second-generation Bruton's Tyrosine Kinase Inhibitors (Acalabrutinib, Zanubrutinib). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07174141 currently recruiting?
Yes, NCT07174141 is actively recruiting participants. Contact the research team at romain.didier@chu-dijon.fr for enrollment information.
Where is the NCT07174141 trial being conducted?
This trial is being conducted at Dijon, France.
Who is sponsoring the NCT07174141 clinical trial?
NCT07174141 is sponsored by Centre Hospitalier Universitaire Dijon. The trial plans to enroll 100 participants.