Atrial Fibrillation (AF), Chronic Lymphocytic Leukemia, Mantle Cell Lymphoma, Marginal Zone Lymphoma, Waldenstrom Macroglobulinemia
Conditions
Keywords
Bruton's Tyrosine Kinase Inhibitor, BTKI, Ibrutinib, Acalabrutinib, Zanubrutinib, Cardio-oncology, ECG patch monitor, Smartwatch monitoring, Arrhythmia, Hematologic malignancy
Brief summary
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.
Interventions
None listed
Sponsors
Tina Baykaner
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Prior exposure to BTKI therapy * History of persistent atrial fibrillation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Atrial Fibrillation | Up to 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AF Burden on BTKI Therapy | Up to 12 months | Proportion of time spent in atrial fibrillation among participants on BTKI therapy, as determined by 14-day ECG patch monitor. |
| Incidence of Other Arrhythmias | Up to 12 months | 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 | Up to 12 months | 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 | Up to 12 months | Number of participants on BTKI therapy who experience treatment interruption, dose reduction, or permanent discontinuation attributed to atrial fibrillation or other arrhythmias. |
| Hospital Admission for Atrial Fibrillation or Other Arrhythmias | Up to 12 months | Number of participants hospitalized for management of atrial fibrillation or other arrhythmias. |
| New Clinical Diagnosis of Hypertension | Up to 12 months | Number of participants with newly diagnosed hypertension during the study period, as documented in the electronic health record. |
| Prescription of Antiplatelet, Anticoagulant, or Rate/Rhythm Control Medication for Atrial Fibrillation | Up to 12 months | Number of participants prescribed antiplatelet, anticoagulant, or rate or rhythm control medications for management of atrial fibrillation, as determined by the treating care team. |
| Incidence of Major Bleeding Events | Up to 12 months | Number of participants with major bleeding events, as documented in the electronic health record. |
| Incidence of Major Adverse Cardiovascular Events (MACE) | Up to 12 months | 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. |
| Referral to Cardiology or Electrophysiology | Up to 12 months | Number of participants referred to cardiology or electrophysiology for evaluation or management during the study period. |
| Overall Survival | At 12 months | Number of participants alive at 12 months following enrollment. |
Countries
United States
Contacts
CONTACTStudy Coordinator
PRINCIPAL_INVESTIGATORTina Baykaner, MD
Stanford University
Outcome results
None listed