Monitoring heart rhythms in patients starting BTK inhibitors
Implanted Loop Recorders (ILR) for the Detection and Management of Arrhythmia in Patients Treated With Bruton Tyrosine Kinase (BTK) Inhibitors
This study is testing how well a heart monitor can detect new heart rhythm problems in patients starting treatment with BTK inhibitors.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Northwell Health Academic / other |
| Drugs / interventions | ibrutinib, acalabrutinib, zanubrutinib, pirtobrutinib |
| Locations | 1 site (New Hyde Park, New York) |
| Trial ID | NCT05643235 on ClinicalTrials.gov |
What this trial studies
This study enrolls patients who are beginning treatment with Bruton Tyrosine Kinase (BTK) inhibitors and have no prior history of arrhythmia. Participants will have a Medtronic LINQ-2 insertable cardiac monitor (ILR) implanted to continuously monitor for new onset atrial fibrillation and other arrhythmias. The study aims to collect data on the incidence of these arrhythmias and the responses to detected episodes over a period of up to 60 months. The approach is prospective and non-blinded, focusing on a single arm of patients receiving BTK therapy.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 who are starting BTK inhibitors for conditions like Chronic Lymphocytic Leukemia and are willing to have a cardiac monitor implanted.
Not a fit: Patients with a history of documented arrhythmia or those with certain recent cardiovascular events may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the management of arrhythmias in patients undergoing BTK inhibitor therapy.
How similar studies have performed: While similar monitoring approaches have been used, this specific application in the context of BTK inhibitors is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * \>18yo * Willing to sign and date consent form, * Willing to be remotely monitored * Initiating BTK inhibitor for approved condition (i.e. CLL, Waldenstrom's, etc) * Willing to have Medtronic cardiac monitor inserted to allow at minimum 24 hours continuous monitoring prior to initiating BTK inhibitor Exclusion Criteria: * Documented AF/VA in past 12 months * Cerebral Vascular Accident (CVA) or Transient Ischemic Attack (TIA) in past year * Has current implanted pulse generator, defibrillator, pacemaker, or resynchronization device * heart surgery within past 90 days * Myocardial Infarction within past 90 days * Patient is taking an anti-arrhythmic or anticoagulant * has concomitant condition that precludes safe participation in study (substance abuse, etc) * Enrollment in separate study that could confound results of this study
Where this trial is running
New Hyde Park, New York
- Northwell (Northshore University/Long Island Jewish Hospitals) — New Hyde Park, New York, United States (Recruiting)
Study contacts
- Principal investigator: Robert S Copeland-Halperin, MD — Northwell Health
- Study coordinator: Efstathia Mihelis
- Email: emihelis@northwell.edu
- Phone: 212-434-6614
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.