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NCT Number: NCT06029166

Subcutaneous Cardiac Monitoring of Patients With BTK Inhibitors

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Caen University Hospital, Department of Pharmacology

Caen, Normandy, France

Location contact

Joachim ALEXANDRE, MDPHD

CONTACT

[email protected]

0231064671

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

    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.

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. IRAF management.

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

  5. 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)

  6. 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)

  7. 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)

  8. Constitute a plasmatic biobank for futures ancillary studies.

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

  9. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Joachim Alexandre, MD, PhD

CONTACT

[email protected]

+33 2.31.06.46.71

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 8, 2023
Registry last updated
Sep 8, 2023

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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