Observational Study of Cardiac Arrhythmias During Treatment With BTK Inhibitors or Venetoclax (NCT05724121) | Clinical Trial Compass
RecruitingNot Applicable
Observational Study of Cardiac Arrhythmias During Treatment With BTK Inhibitors or Venetoclax
United States135 participantsStarted 2023-03-01
Plain-language summary
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 participate
Age range
18 Years – 110 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this study is specifically tracking heart rhythm problems and sudden cardiac death in people taking BTK inhibitors like ibrutinib or acalabrutinib, should I be concerned about my personal heart health history before starting one of these medications?
2This is an observational study, meaning researchers are watching what happens rather than testing a new treatment — so does joining this trial change anything about which drug I would receive or how my care would be managed?
3The study is monitoring cardiac arrhythmias during the first 12 months of BTK inhibitor therapy, so what kind of heart monitoring would I need during that period, and how would that fit into my regular schedule?
4Given that venetoclax is also part of this study, is there a reason my doctor might recommend venetoclax over a BTK inhibitor based on my specific heart health or risk factors?
5Since this study is still recruiting and focuses on serious cardiac events, are there signs or symptoms I should watch for that would be especially important to report right away if I am taking a BTK inhibitor?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
arrhythmogenic cardiac effects of BTKi and sudden death within the first 12 months of BTKi therapy
Timeframe: 12 months
Trial details
NCT IDNCT05724121
SponsorNational Heart, Lung, and Blood Institute (NHLBI)