This study looks at how often atrial fibrillation (AF), an irregular heart rhythm, occurs in people with certain blood cancers who are starting a type of cancer medicine called a Bruton's tyrosine kinase inhibitor (BTKI). Researchers will follow 400 people starting BTKI therapy and compare them to 100 people with similar blood cancers who are not taking a BTKI. Participants will wear a smartwatch and, later, a heart monitor patch to check for AF and other irregular heart rhythms over 12 months. The study will also look at whether AF affects cancer treatment, such as needing to pause, lower the dose, or stop the BTKI, and whether it leads to other health problems such as bleeding, stroke, or heart-related hospital visits.
Age greater than 18 years
Diagnosis of chronic lymphocytic leukemia (CLL), Waldenstrom macroglobulinemia (WM), mantle cell lymphoma (MCL), or marginal zone lymphoma (MZL)
New initiation of Bruton's tyrosine kinase inhibitor (BTKI) therapy or non-BTKI therapy (eg, venetoclax based) for management of hematologic malignancy
Prior exposure to BTKI therapy
History of persistent atrial fibrillation
Adults with a diagnosis of chronic lymphocytic leukemia, Waldenstrom macroglobulinemia, mantle cell lymphoma, or marginal zone lymphoma who are being newly started on BTKI or non-BTKI therapy at Stanford University, City of Hope, or UCSD oncology clinics.
Cohort
Prospective
Not listed
Incidence of Atrial Fibrillation
Incidence of new atrial fibrillation (AF) detected by smartwatch photoplethysmography with confirmatory ECG, and/or by 14-day ECG patch monitor, compared between participants on BTKI therapy and non-BTKI control participants.
AF Burden on BTKI Therapy
Proportion of time spent in atrial fibrillation among participants on BTKI therapy, as determined by 14-day ECG patch monitor.
Incidence of Other Arrhythmias
Incidence of arrhythmias other than atrial fibrillation, including premature atrial contractions (PACs), premature ventricular contractions (PVCs), non-sustained ventricular tachycardia (NSVT), supraventricular tachycardia (SVT), and atrioventricular (AV) blocks, detected by ECG patch monitor or incidental findings on ECG-enabled smartwatch recordings.
Clinical Atrial Fibrillation Diagnosis Not Detected by Smartwatch or ECG Patch Monitor
Number of participants with new atrial fibrillation diagnosed during routine clinical care (primary care visit, emergency department, or hospitalization) that was not identified through smartwatch or ECG patch monitoring.
BTKI Therapy Interruption, Dose Reduction, or Cessation Due to Arrhythmia
Number of participants on BTKI therapy who experience treatment interruption, dose reduction, or permanent discontinuation attributed to atrial fibrillation or other arrhythmias.
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Tina Baykaner
Lead sponsor
Stanford University
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options:
