NCT05724121Recruiting
Observational Study of Cardiac Arrhythmias During Treatment With BTK Inhibitors or Venetoclax
Source: ClinicalTrials.gov · Last updated 29 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 135 (estimated)
- First submitted
- 10 Feb 2023
- Start date
- 1 Mar 2023
- Primary completion date
- 8 Apr 2027
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
- NCT number
- NCT05724121
What you commit to
- Study type: Observational
- Planned participants: 135
- From 1 Mar 2023 to the primary completion date, 8 Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Pregnancy or lactation- use of BTK inhibitors is contraindicated in pregnant or nursing individuals.
Other illness
- Any acute cardiac condition including myocardial infarction or decompensated heart failure within the past 3 months
Other
- An individual who meets any of the following criteria will be excluded from participation in this study:
Criteria the registry did not label
- 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
Age in the registry: 18 years to 110 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Institutes of Health Clinical Center Coordinator of this site? Confirm its status | Bethesda | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.