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NCT05724121 · ClinicalTrials.gov record · last posted 2026-08-07

Observational Study of Cardiac Arrhythmias During Treatment With BTK Inhibitors or Venetoclax

StatusRecruiting
PhaseNot specified
Started2023-03-01
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from the ClinicalTrials.gov record
Background: Bruton s tyrosine kinase inhibitors (BTKi) are used to treat a form of leukemia. But taking BTKi can also increase a person s risk of developing an abnormal heart rhythm. This can cause sudden death. In this natural history study, researchers want to learn how BTKi affects the heart. Objective: To identify and monitor the effects of BTKi on the heart. Eligibility: People aged 18 and older currently receiving or planning to receive BTKi or venetoclax. Design: Participants who have not yet started BTKi will have 2 required clinic visits: 1 before they start taking BTKi, and 1 about 6 months later. Participants who are already taking BTKi will have 1 required visit. Participants will undergo multiple tests: A physical exam, including collection of blood and saliva. A test that measures heart activity via stickers placed on the chest. A test that uses sound waves to capture images of the heart. An exercise stress test that monitors heart activity and blood pressure while the participant works on a treadmill or stationary bike. Sound wave images of the heart may also be taken while the participant exercises. Stress magnetic resonance imaging (MRI) may be done in place of an exercise test. Participants will lie on a table that slides into a tube. They will be given drugs to stress the heart while images are taken. Participants may wear a device to monitor their heart at home. Participants may have repeat visits if they develop heart symptoms or if they need to stop taking BTKi. They will have follow-up phone calls each year for up to 3 years.

Amendment record 116 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 116 times since 2023-02-10; most recent amendment 2026-07-24. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

Trial Details
NCT Number NCT05724121
Lead Sponsor National Heart, Lung, and Blood Institute (NHLBI)
Conditions Chronic Lymphocytic Leukemia (CLL), Waldenstr(SqrRoot)(Delta)m s Macroglobulinemia, Mantle Cell Lymphoma, Sudden Cardiac Death, Cardiac Arrhythmias, Hematologic Malignancies
Enrollment 135 participants
Start Date 2023-03-01
Primary Completion 2027-04-08 (estimated)
Study Completion 2027-04-08 (estimated)
Updated on ClinicalTrials.gov 2026-08-07