Investigating heart complications from ibrutinib therapy
Cardiovascular Complications of Ibrutinib Therapy: a Single-center Cohort Study
This study is testing how ibrutinib treatment for chronic lymphocytic leukemia and other blood disorders affects heart health, especially looking for signs of atrial fibrillation in patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire Dijon Academic / other |
| Drugs / interventions | ibrutinib |
| Locations | 1 site (Dijon) |
| Trial ID | NCT05939752 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the cardiovascular complications associated with ibrutinib therapy, particularly focusing on the incidence of atrial fibrillation (AF) in patients undergoing treatment for chronic lymphocytic leukemia and other hematologic conditions. Patients aged 18 and over who are eligible for ibrutinib treatment will be monitored through regular pulse palpation and ECG assessments. The study seeks to systematically screen for AF, which is often underreported, to better understand the risks associated with this therapy.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and over who are indicated for ibrutinib treatment for hematologic conditions.
Not a fit: Patients with a history of atrial fibrillation or those who have previously received ibrutinib will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and management strategies for patients receiving ibrutinib, potentially reducing the risk of atrial fibrillation.
How similar studies have performed: While there have been studies on the adverse effects of ibrutinib, this specific approach of systematic AF screening in a cohort is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with an indication for ibrutinib treatment for hematologic reasons * Patients aged 18 and over * Patients who have given their free, written and informed consent to this study after being informed (or by the patient's representative if the patient is unable to express his or her consent). Exclusion Criteria: * Person not affiliated to national health insurance * Patient under legal protection (curatorship, guardianship) * Patient subject to a safeguard of justice measure * Pregnant, parturient or breast-feeding women * Previous treatment with ibrutinib * Follow-up planned in another center * History of atrial fibrillation
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: 03.80.29.30.31
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.