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.
Study Type
OBSERVATIONAL
Enrollment
500
City of Hope
Duarte, California, United States
UC San Diego Health
San Diego, California, United States
Stanford Health Care
Stanford, California, United States
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.
Time frame: Up to 12 months
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.
Time frame: Up to 12 months
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.
Time frame: Up to 12 months
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.
Time frame: Up to 12 months
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.
Time frame: Up to 12 months
Hospital Admission for Atrial Fibrillation or Other Arrhythmias
Number of participants hospitalized for management of atrial fibrillation or other arrhythmias.
Time frame: Up to 12 months
New Clinical Diagnosis of Hypertension
Number of participants with newly diagnosed hypertension during the study period, as documented in the electronic health record.
Time frame: Up to 12 months
Prescription of Antiplatelet, Anticoagulant, or Rate/Rhythm Control Medication for Atrial Fibrillation
Number of participants prescribed antiplatelet, anticoagulant, or rate or rhythm control medications for management of atrial fibrillation, as determined by the treating care team.
Time frame: Up to 12 months
Incidence of Major Bleeding Events
Number of participants with major bleeding events, as documented in the electronic health record.
Time frame: Up to 12 months
Incidence of Major Adverse Cardiovascular Events (MACE)
Number of participants with a major adverse cardiovascular event, defined as cardiovascular death, myocardial infarction, unplanned surgical or percutaneous coronary revascularization, hospital admission for arterial thrombosis, or heart failure.
Time frame: Up to 12 months
Referral to Cardiology or Electrophysiology
Number of participants referred to cardiology or electrophysiology for evaluation or management during the study period.
Time frame: Up to 12 months
Overall Survival
Number of participants alive at 12 months following enrollment.
Time frame: At 12 months
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