Atrial Fibrillation in Patients Receiving Ibrutinib
- Conditions
- Leukemia, Chronic LymphaticMantle Cell Lymphoma
- Registration Number
- NCT04407845
- Lead Sponsor
- European Georges Pompidou Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
- All patients deem to start ibrutinib therapy
- Past history of ibrutinib therapy
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Incidence of hemorraghe 6 months Number of patients with hemorraghe
Incidence of supra-ventricular arrythmias 6 months Number of patients with supra-ventricular arrythmias
Incidence of systemic hypertension 6 months Number of patients with systemic hypertension
Incidence of arterial embolism 6 months Number of patients with systemic hypertension
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
Trial Locations
- Locations (1)
Assistance Publique Hôpitaux de Paris - Centre Université de Paris
🇫🇷Paris, France