Biomarkers for heart problems in people taking second-generation BTK inhibitors
Innovative Biomarkers of Cardiovascular Complications Associated With Second-generation Bruton Tyrosine Kinase Inhibitor Treatments: a Single-center Cohort Study
Centre Hospitalier Universitaire Dijon · NCT07174141
This project will closely monitor adults starting acalabrutinib or zanubrutinib to see how often they develop high blood pressure or heart rhythm problems and to find blood or eye markers that predict those complications.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire Dijon (other) |
| Drugs / interventions | acalabrutinib, zanubrutinib, ibrutinib |
| Locations | 1 site (Dijon) |
| Trial ID | NCT07174141 on ClinicalTrials.gov |
What this trial studies
This observational single-center cohort will follow adults treated with second-generation Bruton's tyrosine kinase inhibitors (acalabrutinib or zanubrutinib) at CHU Dijon Bourgogne. Participants will undergo specialized monitoring including regular clinical visits, blood sampling, and ophthalmological examinations to capture cardiovascular events such as arrhythmias and hypertension. The study excludes patients with prior BTKI exposure, a history of atrial fibrillation, uncontrolled hypertension, or planned follow-up at another center. Collected biomarkers and clinical data will be analyzed to determine incidence rates and identify predictors of cardiovascular complications.
Who should consider this trial
Good fit: Adults (age ≥18) who are scheduled to start acalabrutinib or zanubrutinib, can give informed consent, have an expected life expectancy greater than one year, and plan follow-up at CHU Dijon Bourgogne.
Not a fit: People with prior BTKI treatment, a history of atrial fibrillation, uncontrolled hypertension, those followed at another center, pregnant or breastfeeding women, or those under legal protection are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the work could allow earlier identification of patients at risk for high blood pressure or arrhythmias on these drugs so clinicians can monitor or change treatment to reduce harm.
How similar studies have performed: Cardiovascular toxicities with first-generation BTKIs have been well documented and some biomarker signals have been reported, but biomarker-based prediction for second-generation BTKIs remains largely unproven.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Dijon
- CHU Dijon Bourgogne — Dijon, France (RECRUITING)
Study contacts
- Study coordinator: Romain DIDIER
- Email: romain.didier@chu-dijon.fr
- Phone: 0380293031
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Treatment With Second-generation Bruton', s Tyrosine Kinase Inhibitors