Observing heart rhythms in patients treated with BTK inhibitors or venetoclax
Official title: Observational Study of Cardiac Arrhythmias During Treatment With BTK Inhibitors or Venetoclax
Run by National Institutes of Health Clinical Center (CC) · NCT05724121 · Data updated 2026-11-12
This study is testing how Bruton’s tyrosine kinase inhibitors affect heart rhythms in people with chronic lymphocytic leukemia and comparing it to those taking venetoclax to see if there are any risks.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 110 Years |
| Sex | All |
| Enrollment | 135 (estimated) |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Drugs / interventions | ibrutinib |
| Locations | 1 site (Bethesda, Maryland) |
| Status | Recruiting |
| Started | March 1, 2023 |
| Main results expected | April 8, 2027 |
| Study ends | April 8, 2027 |
| Registry record updated | October 29, 2026 |
| Trial ID | NCT05724121 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older who are currently receiving or planning to receive BTK inhibitors or venetoclax.
✕Probably not a fit
Patients with acute cardiac conditions or those who are pregnant or lactating may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to assess the impact of Bruton’s tyrosine kinase inhibitors (BTKi) on cardiac arrhythmias in patients with chronic lymphocytic leukemia (CLL) and other related conditions. Participants aged 18 and older, either starting or currently on BTKi or venetoclax, will undergo comprehensive cardiac evaluations, including physical exams, heart activity tests, and stress tests. The study seeks to identify and monitor the arrhythmogenic effects of BTKi, with the goal of improving patient safety and outcomes. Additionally, it will compare findings with a control group receiving venetoclax, which is not associated with increased cardiac risks.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and management of cardiac risks in patients undergoing treatment with BTK inhibitors.
How similar studies have gone: While studies on cardiac effects of cancer therapies exist, this specific observational approach to monitor BTKi-related cardiac arrhythmias is novel.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
National Institutes of Health Clinical Center
Bethesda, Maryland, United States Recruiting
Study contacts
- Principal investigator: Christine E Gruessner, M.D. — National Heart, Lung, and Blood Institute (NHLBI)
- Study coordinator: Ingrid C Frey
- Email: ingrid.frey@nih.gov
- Phone: (301) 402-0797
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.