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Not yet recruiting NCT06029166

Subcutaneous Cardiac Monitoring of Patients With BTK Inhibitors

No phase Interventional Atrial Fibrillation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Insertable subcutaneous cardiac monitor (BIOMONITOR IIIm®, Biotronik®).
Who it may be relevant to
Registry conditions: Atrial Fibrillation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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.

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. [Time frame: 3, 6, 9 and 12 months after introduction of ibrutinib therapy (+/- 7 days)]
Secondary outcome measures (9)
  • 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)]
  • 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)]
  • 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)]
  • IRAF management. [Time frame: 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. [Time frame: 3, 6, 9 and 12 months after introduction of ibrutinib therapy (+/- 7 days)]
  • 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)]
  • 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)]
  • Constitute a plasmatic biobank for futures ancillary studies. [Time frame: 3, 6, 9 and 12 months after introduction of ibrutinib therapy (+/- 7 days)]
  • 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)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

France · 1 center
  • Caen University Hospital, Department of Pharmacology — Caen

Identifiers

NCT: NCT06029166 · 22-0252

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗