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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BTKI Therapy | Participants with chronic lymphocytic leukemia, Waldenstrom macroglobulinemia, mantle cell lymphoma, or marginal zone lymphoma who are newly initiated on Bruton's tyrosine kinase inhibitor (BTKI) therapy. Participants are offered a smartwatch at enrollment for continuous monitoring and receive a clinically indicated ECG patch monitor 6 months after initiation of therapy if AF has not already been detected. | ||
| Non-BTKI Therapy (Control) | Participants with the same hematologic malignancy diagnoses who are newly initiated on non-BTKI therapy (e.g., venetoclax-based regimens) instead of a BTKI. Participants are offered a smartwatch at enrollment for continuous monitoring and receive a clinically indicated ECG patch monitor 6 months after initiation of therapy if AF has not already been detected. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 12 months |
| Incidence of Other Arrhythmias |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Coordinator | Contact | 707-628-2150 | danieljg@stanford.edu |
| Name | Affiliation | Role |
|---|---|---|
| Tina Baykaner, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope | Duarte | California | 91010 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31722151 | Background | Perez MV, Mahaffey KW, Hedlin H, Rumsfeld JS, Garcia A, Ferris T, Balasubramanian V, Russo AM, Rajmane A, Cheung L, Hung G, Lee J, Kowey P, Talati N, Nag D, Gummidipundi SE, Beatty A, Hills MT, Desai S, Granger CB, Desai M, Turakhia MP; Apple Heart Study Investigators. Large-Scale Assessment of a Smartwatch to Identify Atrial Fibrillation. N Engl J Med. 2019 Nov 14;381(20):1909-1917. doi: 10.1056/NEJMoa1901183. | |
| 36148649 |
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De-identified individual participant data are not currently planned for sharing outside the study team. Data are stored in RedCap, accessible only to research team members, with participant identifiers kept separate in a password-protected code book. This plan may be revised in a future update if a formal data sharing arrangement is established.
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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.
| 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. | 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. | Up to 12 months |
| Hospital Admission for Atrial Fibrillation or Other Arrhythmias | Number of participants hospitalized for management of atrial fibrillation or other arrhythmias. | 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. | 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. | Up to 12 months |
| Incidence of Major Bleeding Events | Number of participants with major bleeding events, as documented in the electronic health record. | 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. | 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. | Up to 12 months |
| Overall Survival | Number of participants alive at 12 months following enrollment. | At 12 months |
| UC San Diego Health | San Diego | California | 92103 | United States |
|
| Stanford Health Care | Stanford | California | 94305 | United States |
|
| Background |
| Lubitz SA, Faranesh AZ, Selvaggi C, Atlas SJ, McManus DD, Singer DE, Pagoto S, McConnell MV, Pantelopoulos A, Foulkes AS. Detection of Atrial Fibrillation in a Large Population Using Wearable Devices: The Fitbit Heart Study. Circulation. 2022 Nov 8;146(19):1415-1424. doi: 10.1161/CIRCULATIONAHA.122.060291. Epub 2022 Sep 23. |
| 32488603 | Background | Archibald WJ, Rabe KG, Kabat BF, Herrmann J, Ding W, Kay NE, Kenderian SS, Muchtar E, Leis JF, Wang Y, Chanan-Khan AA, Schwager SM, Koehler AB, Fonder AL, Slager SL, Shanafelt TD, Call TG, Parikh SA. Atrial fibrillation in patients with chronic lymphocytic leukemia (CLL) treated with ibrutinib: risk prediction, management, and clinical outcomes. Ann Hematol. 2021 Jan;100(1):143-155. doi: 10.1007/s00277-020-04094-3. Epub 2020 Jun 1. |
| 28778946 | Background | Healey JS, Alings M, Ha A, Leong-Sit P, Birnie DH, de Graaf JJ, Freericks M, Verma A, Wang J, Leong D, Dokainish H, Philippon F, Barake W, McIntyre WF, Simek K, Hill MD, Mehta SR, Carlson M, Smeele F, Pandey AS, Connolly SJ; ASSERT-II Investigators. Subclinical Atrial Fibrillation in Older Patients. Circulation. 2017 Oct 3;136(14):1276-1283. doi: 10.1161/CIRCULATIONAHA.117.028845. Epub 2017 Aug 4. |
| 34469766 | Background | Svendsen JH, Diederichsen SZ, Hojberg S, Krieger DW, Graff C, Kronborg C, Olesen MS, Nielsen JB, Holst AG, Brandes A, Haugan KJ, Kober L. Implantable loop recorder detection of atrial fibrillation to prevent stroke (The LOOP Study): a randomised controlled trial. Lancet. 2021 Oct 23;398(10310):1507-1516. doi: 10.1016/S0140-6736(21)01698-6. Epub 2021 Aug 29. |
| 33625468 | Background | Gladstone DJ, Wachter R, Schmalstieg-Bahr K, Quinn FR, Hummers E, Ivers N, Marsden T, Thornton A, Djuric A, Suerbaum J, von Grunhagen D, McIntyre WF, Benz AP, Wong JA, Merali F, Henein S, Nichol C, Connolly SJ, Healey JS; SCREEN-AF Investigators and Coordinators. Screening for Atrial Fibrillation in the Older Population: A Randomized Clinical Trial. JAMA Cardiol. 2021 May 1;6(5):558-567. doi: 10.1001/jamacardio.2021.0038. |
| 27247135 | Background | Leong DP, Caron F, Hillis C, Duan A, Healey JS, Fraser G, Siegal D. The risk of atrial fibrillation with ibrutinib use: a systematic review and meta-analysis. Blood. 2016 Jul 7;128(1):138-40. doi: 10.1182/blood-2016-05-712828. Epub 2016 May 31. No abstract available. |
| 30573111 | Background | Ganatra S, Sharma A, Shah S, Chaudhry GM, Martin DT, Neilan TG, Mahmood SS, Barac A, Groarke JD, Hayek SS, Dani S, Venesy D, Patten R, Nohria A. Ibrutinib-Associated Atrial Fibrillation. JACC Clin Electrophysiol. 2018 Dec;4(12):1491-1500. doi: 10.1016/j.jacep.2018.06.004. Epub 2018 Aug 29. |
| 37256462 | Background | Wei C, Fazal M, Loh A, Kapoor R, Gomez SE, Shah S, Rogers AJ, Narayan SM, Wang PJ, Witteles RM, Perino AC, Cheng P, Rhee JW, Baykaner T. Comparative arrhythmia patterns among patients on tyrosine kinase inhibitors. J Interv Card Electrophysiol. 2024 Jan;67(1):111-118. doi: 10.1007/s10840-023-01575-z. Epub 2023 May 31. |
| 29296820 | Background | Wiczer TE, Levine LB, Brumbaugh J, Coggins J, Zhao Q, Ruppert AS, Rogers K, McCoy A, Mousa L, Guha A, Heerema NA, Maddocks K, Christian B, Andritsos LA, Jaglowski S, Devine S, Baiocchi R, Woyach J, Jones J, Grever M, Blum KA, Byrd JC, Awan FT. Cumulative incidence, risk factors, and management of atrial fibrillation in patients receiving ibrutinib. Blood Adv. 2017 Sep 8;1(20):1739-1748. doi: 10.1182/bloodadvances.2017009720. eCollection 2017 Sep 12. |
| 35047578 | Background | Fazal M, Kapoor R, Cheng P, Rogers AJ, Narayan SM, Wang P, Witteles RM, Perino AC, Baykaner T, Rhee JW. Arrhythmia Patterns in Patients on Ibrutinib. Front Cardiovasc Med. 2022 Jan 3;8:792310. doi: 10.3389/fcvm.2021.792310. eCollection 2021. |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D008258 | Waldenstrom Macroglobulinemia |
| D020522 | Lymphoma, Mantle-Cell |
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| D001145 | Arrhythmias, Cardiac |
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D016393 | Lymphoma, B-Cell |
| D009371 | Neoplasms by Site |
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