Leukemia, Chronic Lymphatic, Mantle Cell Lymphoma
Conditions
Keywords
atrial fibrillation, haematology, systemic hypertension, prognosis, heart
Brief summary
Ibrutinib (a tyrosine kinase inhibitor targeting Bruton) is a standard of treatment in haematology. According to retrospective data, atrial fibrillation and systemic hypertension are common ibrutinib-related advserse events. The investigators aim at prospectively establishing the incidence of thesedrug related advsere events through clinical monitoring and attempt at identifying populations at risk.
Interventions
None listed
Sponsors
European Georges Pompidou Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All patients deem to start ibrutinib therapy
Exclusion criteria
* Past history of ibrutinib therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of cardiovascular events on ibrutinib | 6 months | Evaluate the incidence of cardiotoxicity (composite endpoint) in a cohort of patients referred to a cardio-oncology before initiation of ibrutinib. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of systemic hypertension | 6 months | Number of patients with systemic hypertension |
| Incidence of arterial embolism | 6 months | Number of patients with systemic hypertension |
| Incidence of supra-ventricular arrythmias | 6 months | Number of patients with supra-ventricular arrythmias |
| Safety mesures | 1 year | Compare advsere events in patients with supr-ventricular arrhythmias according to the continuation or discontinuation of ibrutinib |
| Anticoagulants | 1 year | Correlation between anti thrombotic strategies and cardiovascular outcomes |
| Incidence of hemorraghe | 6 months | Number of patients with hemorraghe |
Countries
France
Contacts
Primary ContactMariana Mirabel, MD, PHD
Outcome results
None listed