NCT07711327

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
61mo left

Started Aug 2026

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 17, 2026

Completed
15 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2031

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2031

Last Updated

July 17, 2026

Status Verified

July 1, 2026

Enrollment Period

5 years

First QC Date

July 14, 2026

Last Update Submit

July 14, 2026

Conditions

Atrial Fibrillation (AF)Chronic Lymphocytic LeukemiaWaldenstrom MacroglobulinemiaMantle Cell LymphomaMarginal Zone Lymphoma

Keywords

Bruton's Tyrosine Kinase InhibitorBTKIIbrutinibAcalabrutinibZanubrutinibCardio-oncologyECG patch monitorSmartwatch monitoringArrhythmiaHematologic malignancy

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (11)

  • AF Burden on BTKI Therapy

    Up to 12 months

  • Incidence of Other Arrhythmias

    Up to 12 months

  • Clinical Atrial Fibrillation Diagnosis Not Detected by Smartwatch or ECG Patch Monitor

    Up to 12 months

  • BTKI Therapy Interruption, Dose Reduction, or Cessation Due to Arrhythmia

    Up to 12 months

  • Hospital Admission for Atrial Fibrillation or Other Arrhythmias

    Up to 12 months

  • +6 more secondary outcomes

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

City of Hope

Duarte, California, 91010, United States

Location

UC San Diego Health

San Diego, California, 92103, United States

Location

Stanford Health Care

Stanford, California, 94305, United States

Location

Related Publications (11)

  • 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.

    PMID: 31722151BACKGROUND

  • 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: 36148649BACKGROUND

  • 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.

    PMID: 32488603BACKGROUND

  • 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: 28778946BACKGROUND

  • 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: 34469766BACKGROUND

  • 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.

    PMID: 33625468BACKGROUND

  • 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: 27247135BACKGROUND

  • 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: 30573111BACKGROUND

  • 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.

    PMID: 37256462BACKGROUND

  • 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.

    PMID: 29296820BACKGROUND

  • 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.

    PMID: 35047578BACKGROUND

MeSH Terms

Conditions

Atrial FibrillationLeukemia, Lymphocytic, Chronic, B-CellWaldenstrom MacroglobulinemiaLymphoma, Mantle-CellLymphoma, B-Cell, Marginal ZoneArrhythmias, CardiacHematologic Neoplasms

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsLeukemia, B-CellLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersLymphoma, Non-HodgkinLymphomaLymphoma, B-CellNeoplasms by Site

Study Officials

  • Tina Baykaner, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Coordinator

CONTACT

707-628-2150danieljg@stanford.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor of Medicine (Cardiovascular Medicine)

Study Record Dates

First Submitted

July 14, 2026

First Posted

July 17, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

August 1, 2031

Study Completion (Estimated)

August 1, 2031

Last Updated

July 17, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

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.

Locations

US(3)