Atrial Fibrillation Among Patients With Hematologic Malignancies on Tyrosine Kinase Inhibitor Therapy

Обзор

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.

Первичные конечные точки

• Incidence of Atrial Fibrillation [Срок оценки: Up to 12 months]

Вторичные конечные точки (11)

• AF Burden on BTKI Therapy [Срок оценки: Up to 12 months]
• Incidence of Other Arrhythmias [Срок оценки: Up to 12 months]
• Clinical Atrial Fibrillation Diagnosis Not Detected by Smartwatch or ECG Patch Monitor [Срок оценки: Up to 12 months]
• BTKI Therapy Interruption, Dose Reduction, or Cessation Due to Arrhythmia [Срок оценки: Up to 12 months]
• Hospital Admission for Atrial Fibrillation or Other Arrhythmias [Срок оценки: Up to 12 months]
• New Clinical Diagnosis of Hypertension [Срок оценки: Up to 12 months]
• Prescription of Antiplatelet, Anticoagulant, or Rate/Rhythm Control Medication for Atrial Fibrillation [Срок оценки: Up to 12 months]
• Incidence of Major Bleeding Events [Срок оценки: Up to 12 months]
• Incidence of Major Adverse Cardiovascular Events (MACE) [Срок оценки: Up to 12 months]
• Referral to Cardiology or Electrophysiology [Срок оценки: Up to 12 months]
• Overall Survival [Срок оценки: At 12 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• Prior exposure to BTKI therapy
• History of persistent atrial fibrillation

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 3 центра

• City of Hope — Duarte
• UC San Diego Health — San Diego
• Stanford Health Care — Stanford

Публикации

• 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/ PMID 31722151
• 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. PMID 36148649
• 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/s PMID 32488603
• 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. PMID 28778946
• 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. PMID 34469766
• 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: 10.1 PMID 33625468
• 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. PMID 27247135
• 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. PMID 30573111

Идентификаторы

NCT: NCT07711327 · 85203

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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