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

Description

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.

Conditions

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

Study Overview

Study Details

Study overview

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.

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

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

Condition
Chronic Lymphocytic Leukemia (CLL)
Intervention / Treatment

-

Contacts and Locations

Bethesda

National Institutes of Health Clinical Center, Bethesda, Maryland, United States, 20892

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Currently receiving or planning to receive a BTKi or venetoclax.
  • 2. Male or female, aged 18 or older
  • 3. Stated willingness to comply with all study procedures and availability for the duration of the study
  • 4. Ability of subject to understand and the willingness to sign a written informed consent document
  • 1. Any acute cardiac condition including myocardial infarction or decompensated heart failure within the past 3 months
  • 2. Pregnancy or lactation- use of BTK inhibitors is contraindicated in pregnant or nursing individuals.

Ages Eligible for Study

18 Years to 110 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

National Heart, Lung, and Blood Institute (NHLBI),

Christine E Gruessner, M.D., PRINCIPAL_INVESTIGATOR, National Heart, Lung, and Blood Institute (NHLBI)

Study Record Dates

2027-04-08