Caen University Hospital, Department of Pharmacology
Caen, Normandy, France
NCT Number: NCT06029166
The goal of this clinical trial is to screen all types of electrocardiographic changes and rhythm disorders in adult patients with a hematologic malignancy requiring a treatment by Bruton's tyrosine kinase (BTK) inhibitor (ibrutinib, acalabrutinib, zanubrutinib) using an insertable subcutaneous cardiac monitor (ISCM) and occurring from inclusion and within 12 months.
This study consists of the implantation of an ISCM at inclusion and before BTK inhibitor initiation. Then patients will have medical visits every 3 months (+/- 7 days) during 12 months and a continuous cardiac telemonitoring using the ISCM.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Caen, Normandy, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Implantation of a subcutaneous cardiac monitor (BIOMONITOR IIIm®, Biotronik®) before beginning the Bruton's tyrosine kinase inhibitor treatment.
Time frame: 3, 6, 9 and 12 months after introduction of ibrutinib therapy (+/- 7 days)
Electrocardiographic changes and/or rhythm disorders are defined by the European Society of Cardiology guidelines.
Time frame: 3, 6, 9 and 12 months after introduction of ibrutinib therapy (+/- 7 days)
Time frame: 3, 6, 9 and 12 months after introduction of ibrutinib therapy (+/- 7 days)
Time frame: 3, 6, 9 and 12 months after introduction of ibrutinib therapy (+/- 7 days)
Time frame: 3, 6, 9 and 12 months after introduction of ibrutinib therapy (+/- 7 days)
Time frame: 3, 6, 9 and 12 months after introduction of ibrutinib therapy (+/- 7 days)
Time frame: 3, 6, 9 and 12 months after introduction of ibrutinib therapy (+/- 7 days)
Time frame: 3, 6, 9 and 12 months after introduction of ibrutinib therapy (+/- 7 days)
Time frame: 3, 6, 9 and 12 months after introduction of ibrutinib therapy (+/- 7 days)
Time frame: 3, 6, 9 and 12 months after introduction of ibrutinib therapy (+/- 7 days)
Contact information is provided by the study sponsor or research team.
University Hospital, Caen
Other
Electrocardiographic Changes and Rhythm Disorders Associated With BTK Inhibitors Exposure Using an Insertable Subcutaneous Cardiac Monitor: a Multicenter Cardio-Oncology Prospective Cohort
Acronym: IRAF-ISCM
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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