NCT05724121 Observational Study of Cardiac Arrhythmias During Treatment With BTK Inhibitors or Venetoclax
| NCT ID | NCT05724121 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Heart, Lung, and Blood Institute (NHLBI) |
| Condition | Chronic Lymphocytic Leukemia (CLL) |
| Study Type | OBSERVATIONAL |
| Enrollment | 135 participants |
| Start Date | 2023-03-01 |
| Primary Completion | 2027-04-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 135 participants in total. It began in 2023-03-01 with a primary completion date of 2027-04-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. ...
Eligibility Criteria
* INCLUSION CRITERIA: To be eligible to participate in this study, an individual must meet all of the following 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 EXCLUSION CRITERIA: An individual who meets any of the following criteria will be excluded from participation in this study: 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.
Contact & Investigator
Christine E Gruessner, M.D.
PRINCIPAL INVESTIGATOR
National Heart, Lung, and Blood Institute (NHLBI)
Frequently Asked Questions
Who can join the NCT05724121 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 110 Years, studying Chronic Lymphocytic Leukemia (CLL). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05724121 currently recruiting?
Yes, NCT05724121 is actively recruiting participants. Contact the research team at ingrid.frey@nih.gov for enrollment information.
Where is the NCT05724121 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT05724121 clinical trial?
NCT05724121 is sponsored by National Heart, Lung, and Blood Institute (NHLBI). The principal investigator is Christine E Gruessner, M.D. at National Heart, Lung, and Blood Institute (NHLBI). The trial plans to enroll 135 participants.
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