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Observational Study of Cardiac Arrhythmias During Treatment With BTK Inhibitors or Venetoclax

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 110 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 1 visit
  • Time periods mentioned: 3 years
  • Procedures mentioned: Physical exams, MRI scans, Wearing a device, Phone or video check-ins

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "Stress magnetic resonance imaging (MRI) may be done in place of an exercise test."
  • "Participants may wear a device to monitor their heart at home."
  • "They will have follow-up phone calls each year for up to 3 years."
Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tracks how BTK inhibitors affect the heart, including abnormal heart rhythms. It is for adults age 18 or older who are taking or plan to take a BTK inhibitor or venetoclax. Participants will have heart tests and yearly follow-up calls for up to 3 years.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are taking or plan to take a BTK inhibitor or venetoclax.
  • You are age 18 or older.
  • You are willing to follow all study steps and stay available for the full study.
  • You can understand the study and are willing to sign a form agreeing to take part.

Who can't join

  • You have had a sudden or severe heart problem in the past 3 months, such as a heart attack or worsening heart failure, when the heart cannot pump enough blood.
  • You are pregnant or breastfeeding. BTK inhibitors must not be used during pregnancy or breastfeeding.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

MD