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Subcutaneous Cardiac Monitoring of Patients With BTK Inhibitors (IRAF-ISCM)

Primary Purpose

Atrial Fibrillation

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Insertable subcutaneous cardiac monitor (BIOMONITOR IIIm®, Biotronik®)
Sponsored by
University Hospital, Caen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Atrial Fibrillation focused on measuring cardio-oncology, cardiotoxicity, hematologic malignancy, atrial fibrillation, rhythm disorders, insertable subcutaneous cardiac monitor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Caen University Hospital, Department of Pharmacology

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Hematologic malignancy patients requiring a treatment by Bruton's tyrosine kinase inhibitor

Arm Description

Consecutive adult patients with a definite diagnosis of hematologic malignancy requiring a treatment by Bruton's tyrosine kinase (BTK) inhibitor (ibrutinib, acalabrutinib, zanubrutinib) during at least 12 months will be included to receive an insertable subcutaneous cardiac monitor (ISCM).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Electrocardiographic intervals (PR, QRS, QT) measurements on both 12-lead ECG and ISCM at baseline and with BTK inhibitors exposure.
The occurrence of bleeding events from inclusion and within 12 months.
Correlation between IRAF and multiple demographic, clinical, cardiac imaging (morphological data) and serum cardiac biomarkers.
IRAF management.
Progression-free survival of patients treated by BTK inhibitors according to the presence of IRAF.
Correlation between QT/QTc measurements performed by ISCM (BIOMONITOR IIIm®, Biotronik®) and a QT expert on 12-leads ECG.
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.
Constitute a plasmatic biobank for futures ancillary studies.
The need for ISCM (BIOMONITOR IIIm®, Biotronik®) remove within the 12-months follow-up.

Full Information

First Posted
August 28, 2023
Last Updated
September 6, 2023
Sponsor
University Hospital, Caen
Collaborators
University Hospital, Marseille, Groupe Hospitalier Pitie-Salpetriere, European Georges Pompidou Hospital, Hôpital Necker-Enfants Malades, Saint Antoine University Hospital, Hospices Civils de Lyon, Centre Hospitalier Universitaire de Saint Etienne, Biotronik SE & Co. KG
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1. Study Identification

Unique Protocol Identification Number
NCT06029166
Brief Title
Subcutaneous Cardiac Monitoring of Patients With BTK Inhibitors
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
October 1, 2026 (Anticipated)
Study Completion Date
October 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen
Collaborators
University Hospital, Marseille, Groupe Hospitalier Pitie-Salpetriere, European Georges Pompidou Hospital, Hôpital Necker-Enfants Malades, Saint Antoine University Hospital, Hospices Civils de Lyon, Centre Hospitalier Universitaire de Saint Etienne, Biotronik SE & Co. KG

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
cardio-oncology, cardiotoxicity, hematologic malignancy, atrial fibrillation, rhythm disorders, insertable subcutaneous cardiac monitor

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hematologic malignancy patients requiring a treatment by Bruton's tyrosine kinase inhibitor
Arm Type
Other
Arm Description
Consecutive adult patients with a definite diagnosis of hematologic malignancy requiring a treatment by Bruton's tyrosine kinase (BTK) inhibitor (ibrutinib, acalabrutinib, zanubrutinib) during at least 12 months will be included to receive an insertable subcutaneous cardiac monitor (ISCM).
Intervention Type
Device
Intervention Name(s)
Insertable subcutaneous cardiac monitor (BIOMONITOR IIIm®, Biotronik®)
Intervention Description
Implantation of a subcutaneous cardiac monitor (BIOMONITOR IIIm®, Biotronik®) before beginning the Bruton's tyrosine kinase inhibitor treatment.
Primary Outcome Measure Information:
Title
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.
Description
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)
Secondary Outcome Measure Information:
Title
Electrocardiographic intervals (PR, QRS, QT) measurements on both 12-lead ECG and ISCM at baseline and with BTK inhibitors exposure.
Time Frame
3, 6, 9 and 12 months after introduction of ibrutinib therapy (+/- 7 days)
Title
The occurrence of bleeding events from inclusion and within 12 months.
Time Frame
3, 6, 9 and 12 months after introduction of ibrutinib therapy (+/- 7 days)
Title
Correlation between IRAF and multiple demographic, clinical, cardiac imaging (morphological data) and serum cardiac biomarkers.
Time Frame
3, 6, 9 and 12 months after introduction of ibrutinib therapy (+/- 7 days)
Title
IRAF management.
Time Frame
3, 6, 9 and 12 months after introduction of ibrutinib therapy (+/- 7 days)
Title
Progression-free survival of patients treated by BTK inhibitors according to the presence of IRAF.
Time Frame
3, 6, 9 and 12 months after introduction of ibrutinib therapy (+/- 7 days)
Title
Correlation between QT/QTc measurements performed by ISCM (BIOMONITOR IIIm®, Biotronik®) and a QT expert on 12-leads ECG.
Time Frame
3, 6, 9 and 12 months after introduction of ibrutinib therapy (+/- 7 days)
Title
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.
Time Frame
3, 6, 9 and 12 months after introduction of ibrutinib therapy (+/- 7 days)
Title
Constitute a plasmatic biobank for futures ancillary studies.
Time Frame
3, 6, 9 and 12 months after introduction of ibrutinib therapy (+/- 7 days)
Title
The need for ISCM (BIOMONITOR IIIm®, Biotronik®) remove within the 12-months follow-up.
Time Frame
3, 6, 9 and 12 months after introduction of ibrutinib therapy (+/- 7 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joachim Alexandre, MD, PhD
Phone
+33 2.31.06.46.71
Email
alexandre-j@chu-caen.fr
Facility Information:
Facility Name
Caen University Hospital, Department of Pharmacology
City
Caen
State/Province
Normandie
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joachim ALEXANDRE, MDPHD
Phone
0231064671
Email
alexandre-j@chu-caen.fr

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Subcutaneous Cardiac Monitoring of Patients With BTK Inhibitors

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