Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07711327

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Atrial Fibrillation (AF) Arrhythmias, Cardiac Atrial Fibrillation Blood Protein Disorders Cardiovascular Diseases Chronic Disease Chronic Lymphocytic Leukemia Disease Attributes Heart Diseases Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, B-Cell, Marginal Zone Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Mantle Cell Lymphoma Marginal Zone Lymphoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Plasma Cell Paraproteinemias Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases Waldenstrom Macroglobulinemia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

City of Hope, Duarte, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Incidence of Atrial Fibrillation

    Time frame: 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 outcomes

  1. AF Burden on BTKI Therapy

    Time frame: Up to 12 months

    Proportion of time spent in atrial fibrillation among participants on BTKI therapy, as determined by 14-day ECG patch monitor.

  2. Incidence of Other Arrhythmias

    Time frame: 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.

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

    Time frame: 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.

  4. BTKI Therapy Interruption, Dose Reduction, or Cessation Due to Arrhythmia

    Time frame: 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.

  5. Hospital Admission for Atrial Fibrillation or Other Arrhythmias

    Time frame: Up to 12 months

    Number of participants hospitalized for management of atrial fibrillation or other arrhythmias.

  6. New Clinical Diagnosis of Hypertension

    Time frame: Up to 12 months

    Number of participants with newly diagnosed hypertension during the study period, as documented in the electronic health record.

  7. Prescription of Antiplatelet, Anticoagulant, or Rate/Rhythm Control Medication for Atrial Fibrillation

    Time frame: 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.

  8. Incidence of Major Bleeding Events

    Time frame: Up to 12 months

    Number of participants with major bleeding events, as documented in the electronic health record.

  9. Incidence of Major Adverse Cardiovascular Events (MACE)

    Time frame: 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.

  10. Referral to Cardiology or Electrophysiology

    Time frame: Up to 12 months

    Number of participants referred to cardiology or electrophysiology for evaluation or management during the study period.

  11. Overall Survival

    Time frame: At 12 months

    Number of participants alive at 12 months following enrollment.

Study contacts

Contact information is provided by the study sponsor or research team.

Study Coordinator

CONTACT

[email protected]

707-628-2150

Sponsors and collaborators

Lead sponsor

Tina Baykaner

Other

Registry information

Important dates

Study start
2026
Primary completion
2031
Study completion
2031
First posted
Jul 17, 2026
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.