Subcutaneous Cardiac Monitoring of Patients With BTK Inhibitors

NCT06029166 | Not Yet Recruiting DMC

• 1 other identifier: 22-0252
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Keywords

cardio-oncology; cardiotoxicity; hematologic malignancy; atrial fibrillation; rhythm disorders; insertable subcutaneous cardiac monitor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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)

• The occurrence of bleeding events from inclusion and within 12 months.

  3, 6, 9 and 12 months after introduction of ibrutinib therapy (+/- 7 days)

• 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)

• IRAF management.

  3, 6, 9 and 12 months after introduction of ibrutinib therapy (+/- 7 days)

• 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)

Study Arms (1)

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

OTHER

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).

Device: Insertable subcutaneous cardiac monitor (BIOMONITOR IIIm®, Biotronik®)

Interventions

Insertable subcutaneous cardiac monitor (BIOMONITOR IIIm®, Biotronik®) DEVICE

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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,
• 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,
• 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.

Sponsors & Collaborators

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

Study Sites (1)

Caen University Hospital, Department of Pharmacology

Caen, Normandy, France

Location

MeSH Terms

Conditions

Atrial Fibrillation; Cardiotoxicity; Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries; Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Joachim Alexandre, MD, PhD

CONTACT

+33 2.31.06.46.71; alexandre-j@chu-caen.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2023
• First Posted: September 8, 2023
• Study Start: October 1, 2023
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: September 8, 2023

Record last verified: 2023-07

Locations

FR (1)