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

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Study ID
NCT05724121
Status
Recruiting
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Conditions

  • Cardiac Arrhythmias
  • Chronic Lymphocytic Leukemia (CLL)
  • Hematologic Malignancies
  • Mantle Cell Lymphoma
  • Sudden Cardiac Death
  • Waldenstr(SqrRoot)(Delta)m s Macroglobulinemia

Eligibility Criteria

Sex
ALL
Age
18 Years - 110 Years
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Mar 1, 2023
Status verified
Feb 2026
Primary completion
Apr 8, 2027
Completion
Apr 8, 2027

Study Design

Enrollment
135 participants (estimated)

Arms

  • Arm: Cohort A
    includes all patients prior to starting therapy with a BTKi
  • Arm: Cohort B
    includes all patients already on therapy with a BTKi
  • Arm: Cohort C
    includes all patients prior to starting therapy with venetoclax

Primary Outcome Measure

arrhythmogenic cardiac effects of BTKi and sudden death within the first 12 months of BTKi therapy [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892
NIH Clinical Center Office of Patient Recruitment (OPR)
[email protected]
800-411-1222

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By research site
National Institutes of Health Clinical Center· Bethesda, MD

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