Observational Study of Cardiac Arrhythmias During Treatment With BTK Inhibitors or Venetoclax
Recruiting · NCT05724121 · Observational (researchers observe without assigning treatment) · Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Inclusion criteria
- To be eligible to participate in this study, an individual must meet all of the following criteria:
- Currently receiving or planning to receive a BTKi or venetoclax.
- Male or female, aged 18 or older
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Ability of subject to understand and the willingness to sign a written informed consent document
Exclusion criteria
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Any acute cardiac condition including myocardial infarction or decompensated heart failure within the past 3 months
- Pregnancy or lactation- use of BTK inhibitors is contraindicated in pregnant or nursing individuals.
Where it is running
1 location listed across 1 US state.
- National Institutes of Health Clinical Center - Bethesda, Maryland, United States