Actively Recruiting
Observational Study of Cardiac Arrhythmias During Treatment With BTK Inhibitors or Venetoclax
Led by National Heart, Lung, and Blood Institute (NHLBI) · Updated on 2026-06-05
135
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how Bruton tyrosine kinase inhibitors (BTKi), used to treat certain blood cancers like chronic lymphocytic leukemia, affect the heart. Since BTKi may increase the risk of abnormal heart rhythms that can lead to sudden death, this observational study aims to monitor these heart effects carefully. Venetoclax, another therapy for similar conditions, is included for comparison as it has not been linked to heart problems. Participants are grouped based on their treatment status: those about to start BTKi, those already receiving BTKi, and those starting venetoclax. Those not yet on BTKi will have two clinic visits, one before starting treatment and another about six months later, while those already on BTKi will have one visit. Various heart tests are performed, including physical exams, blood and saliva collection, heart activity monitoring with chest stickers, heart imaging with sound waves, and exercise stress tests or stress MRI scans. Some participants may wear a heart monitor at home and have additional visits if heart symptoms develop or treatment stops. During the study, participants undergo thorough heart assessments to detect arrhythmias and sudden cardiac events. Researchers collect data through tests, imaging, and follow-up phone calls annually for up to three years. The main outcomes measured include the development of serious heart rhythm problems and sudden death within the first year of BTKi therapy. The study also evaluates the usefulness of different heart tests and explores factors like drug levels, genetics, and other health conditions related to heart risks.
CONDITIONS
Brief Title
Observational Study of Cardiac Arrhythmias During Treatment With BTK Inhibitors or Venetoclax
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Currently receiving or planning to receive a BTKi or venetoclax
- Male or female, aged 18 or older
- Willing to comply with all study procedures and available for the duration of the study
- Able to understand and willing to sign a written informed consent document
You will not qualify if you...
- Any acute cardiac condition including heart attack or decompensated heart failure within the past 3 months
- Pregnancy or breastfeeding; use of BTK inhibitors is not allowed in pregnant or nursing individuals
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Prior to therapy initiation
Participants undergo comprehensive cardiac evaluations prior to starting therapy to identify any existing cardiac arrhythmias.
1 to 2 visits depending on cohort assignment
Duration - Up to 36 months
Participants are monitored with routine cardiac assessments during and after therapy to detect arrhythmias and sudden cardiac events.
Periodic visits for cardiac monitoring during therapy
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
I
Ingrid C Frey
C
Christine E Gruessner, M.D.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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