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Acalabrutinib

Tyrosine Kinase Inhibitors

Tyrosine

no intervention

Michael Fradley, MD

Acalabrutinib and Zanabrutinib are highly effective drugs used to treat Chronic Lymphocytic Leukemia, but they are associated with high blood pressure and abnormal heart rhythms. SENTINEL is an observational study that will use wearable technology to monitor heart rhythm and blood pressures at home to better understand how frequently patients are experiencing high blood pressure and/or abnormal heart rhythms.

Given the significant morbidity and mortality associated with hypertension and AF including stroke, systemic thromboembolism and heart failure, monitoring asymptomatic patients who are at high risk is an important area of investigation in the general population and is clearly an area of substantial need in the setting of BTK inhibitor use. Leveraging technology (including wearable and digital devices) to evaluate for the development of arrhythmias is an area of increasing focus in the field of cardiology and has led to various partnerships with technology companies including Apple, Google and Amazon. Several devices have shown promise in their ability to detect subclinical arrhythmias including patch and implantable recording devices, Smartwatches and digital sensors. Given the unmet need to better quantitate hypertension and arrhythmia burden in patients treated with BTK inhibitors, the investigators propose a study in which a SmartWatch, as well as at home blood pressure monitoring is used to monitor for the development of arrhythmias in either acalabrutinib- or zanubrutinib-treated CLL patients to better determine incidence and prevalence in a real world population. Based on these data, the investigators will be able to provide optimal treatment to patients while also ensuring accurate representation of hypertension and arrhythmia toxicity data which may translate into reductions in long term cardiovascular morbidity and mortality.

Hypertension and Arrhythmias in CLL Patients Treated With BTK Inhibitors

A Prospective Longitudinal Cohort Study of the Incidence of Hypertension and Arrhythmias In Patients Treated With Bruton's Tyrosine Kinase Inhibitors For Chronic Lymphocytic Leukemia Using Wearable Technology

New onset or worsening hypertension recorded on home blood pressure monitoring

Any episode of atrial or ventricular arrhythmias identified via wearable device monitoring

Incident episode of stroke/TIA, other thromboembolic events, heart failure, ischemic hear events

determination of the rate of Bruton's Tyrosine Kinase inhibitor discontinuation after development of arrhythmia

Abramson Cancer Center at Penn Medicine

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Hypertension and Arrhythmias in CLL Patients Treated With BTK Inhibitors	NCT06211413	Chronic Lymphoc... Atrial Fibrilla... Hypertension Cardiotoxicity	no intervention	22 Years -	Abramson Cancer Center at Penn Medicine
Hypertension and Arrhythmias in CLL Patients Treated With BTK Inhibitors	NCT06211413	Chronic Lymphoc... Atrial Fibrilla... Hypertension Cardiotoxicity	no intervention	22 Years -	Abramson Cancer Center at Penn Medicine

Spots Global Cancer Trial Database for zanabrutinib

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