Subcutaneous Cardiac Monitoring of Patients With BTK Inhibitors

Atrial Fibrillation Clinical Trial

— IRAF-ISCM  

Official title:

Electrocardiographic Changes and Rhythm Disorders Associated With BTK Inhibitors Exposure Using an Insertable Subcutaneous Cardiac Monitor: a Multicenter Cardio-Oncology Prospective Cohort

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06029166
• Other study ID #: 22-0252
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: October 1, 2026

Study information

• Verified date: July 2023
• Source: University Hospital, Caen
• Contact: Joachim Alexandre, MD, PhD
• Phone: +33 2.31.06.46.71
• Email: alexandre-j[@]chu-caen.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: October 1, 2026
• Est. primary completion date: October 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients,
• Definite diagnosis of hematologic malignancy requiring a BTK inhibition with ibrutinib, acalabrutinib or zanubrutinib,
• Expected BTK inhibitor duration estimated to be at least 12 months,
• Sinus rhythm at enrolment,
• Willing to sign patient consent form and to comply with scheduled visits, as outlined in the protocol

Exclusion Criteria:

• Age < 18 years old,
• Adults with protective measures (curatorship or tutorship) and vulnerable patients,
• Pregnant or nursing women,
• Permanent atrial fibrillation or long-standing persistent atrial fibrillation as defined by the European Society of Cardiology guidelines,
• Atrial fibrillation on the electrocardiogram at the inclusion visit,
• Previous left atrial ablation or previous maze or maze-like surgery,
• Indication for or patients with a pacemaker or implantable cardioverter-defibrillator at baseline,
• Untreated hyperthyroidism,
• Uncorrected kaliaemia disorders at the inclusion visit,
• Hemoglobin < 8 g/L at the inclusion visit,
• Thrombopenia < 50,000/mm3 at the inclusion visit,
• Active bleeding,
• Myocardial infarction < 1 month,
• Surgery < 1 month,
• Mechanical heart valve,
• Valvular heart disease requiring surgery,
• Inability to follow the required procedures of the clinical investigation plan,
• No signature of patient consent form.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• Insertable subcutaneous cardiac monitor (BIOMONITOR IIIm®, Biotronik®)
Implantation of a subcutaneous cardiac monitor (BIOMONITOR IIIm®, Biotronik®) before beginning the Bruton's tyrosine kinase inhibitor treatment.

Locations

Country	Name	City	State
France	Caen University Hospital, Department of Pharmacology	Caen	Normandie

Sponsors (9)

Lead Sponsor	Collaborator
University Hospital, Caen	Biotronik SE & Co. KG, Centre Hospitalier Universitaire de Saint Etienne, European Georges Pompidou Hospital, Groupe Hospitalier Pitie-Salpetriere, Hôpital Necker-Enfants Malades, Hospices Civils de Lyon, Saint Antoine University Hospital, University Hospital, Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of any electrocardiographic changes and/or rhythm disorders from first BTK inhibitors prescription to 12 months of follow-up, symptomatic or not, detected on 12-lead ECG and/or on ISCM.	Electrocardiographic changes and/or rhythm disorders are defined by the European Society of Cardiology guidelines.	3, 6, 9 and 12 months after introduction of ibrutinib therapy (+/- 7 days)
Secondary	Electrocardiographic intervals (PR, QRS, QT) measurements on both 12-lead ECG and ISCM at baseline and with BTK inhibitors exposure.		3, 6, 9 and 12 months after introduction of ibrutinib therapy (+/- 7 days)
Secondary	The occurrence of bleeding events from inclusion and within 12 months.		3, 6, 9 and 12 months after introduction of ibrutinib therapy (+/- 7 days)
Secondary	Correlation between IRAF and multiple demographic, clinical, cardiac imaging (morphological data) and serum cardiac biomarkers.		3, 6, 9 and 12 months after introduction of ibrutinib therapy (+/- 7 days)
Secondary	IRAF management.		3, 6, 9 and 12 months after introduction of ibrutinib therapy (+/- 7 days)
Secondary	Progression-free survival of patients treated by BTK inhibitors according to the presence of IRAF.		3, 6, 9 and 12 months after introduction of ibrutinib therapy (+/- 7 days)
Secondary	Correlation between QT/QTc measurements performed by ISCM (BIOMONITOR IIIm®, Biotronik®) and a QT expert on 12-leads ECG.		3, 6, 9 and 12 months after introduction of ibrutinib therapy (+/- 7 days)
Secondary	Daily body temperature monitoring with the ISCM (BIOMONITOR IIIm®, Biotronik®) temperature sensor and will be compared with conventional body temperature measurements performed during follow-up visits.		3, 6, 9 and 12 months after introduction of ibrutinib therapy (+/- 7 days)
Secondary	Constitute a plasmatic biobank for futures ancillary studies.		3, 6, 9 and 12 months after introduction of ibrutinib therapy (+/- 7 days)
Secondary	The need for ISCM (BIOMONITOR IIIm®, Biotronik®) remove within the 12-months follow-up.		3, 6, 9 and 12 months after introduction of ibrutinib therapy (+/- 7 days)