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

Part of paid clinical trials in Duarte, California.

Sponsor
Tina Baykaner
Study ID
NCT07711327
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

First listed
Jul 17, 2026
Start date
Aug 31, 2026
Status verified
Jul 2026
Primary completion
Aug 31, 2031
Completion
Aug 31, 2031

Study Design

Enrollment
500 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

Incidence of Atrial Fibrillation [ Time Frame: Up to 12 months ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010
Study Coordinator
[email protected]
800-826-4673
June-Wha Rhee, MD (SUB_INVESTIGATOR)
UC San Diego HealthSan DiegoCalifornia92103
Ruby Swaim
[email protected]
858-246-2510
Anna Narezkina, MD (SUB_INVESTIGATOR)
Stanford Health CareStanfordCalifornia94305
Daniel Gonzalez, MTM
[email protected]
707-628-2150
Tina Baykaner, MD (PRINCIPAL_INVESTIGATOR)

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