Biomarkers for heart problems in people taking second-generation BTK inhibitors
Official title: Innovative Biomarkers of Cardiovascular Complications Associated With Second-generation Bruton Tyrosine Kinase Inhibitor Treatments: a Single-center Cohort Study
Run by Centre Hospitalier Universitaire Dijon · NCT07174141 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Centre Hospitalier Universitaire Dijon Academic / other |
| Drugs / interventions | acalabrutinib, zanubrutinib, ibrutinib |
| Locations | 1 site (Dijon) |
| Status | Recruiting |
| Started | November 28, 2025 |
| Main results expected | November 2028 |
| Study ends | November 2028 |
| Registry record updated | December 4, 2025 |
| Trial ID | NCT07174141 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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CHU Dijon Bourgogne
Dijon, France Recruiting
Study contacts
- Study coordinator: Romain DIDIER
- Email: romain.didier@chu-dijon.fr
- Phone: 0380293031
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.