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

Launched by NATIONAL HEART, LUNG, AND BLOOD INSTITUTE (NHLBI) · Feb 10, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how certain cancer treatments, specifically Bruton’s tyrosine kinase inhibitors (BTKi) and venetoclax, affect heart health. These medications are often used for conditions like chronic lymphocytic leukemia (CLL) and mantle cell lymphoma, but they may increase the risk of abnormal heart rhythms, which can be serious. The goal of the study is to closely monitor participants' heart health while they are on these treatments.

To participate, individuals must be 18 years or older and currently taking or planning to take either BTKi or venetoclax. Participants will need to visit the clinic for tests, including heart activity monitoring and imaging, both before starting the treatment and at intervals afterward. For those already on treatment, only one visit is needed. Throughout the study, participants may also wear a heart-monitoring device at home and will have follow-up calls for up to three years to check in on their health. This study is important for understanding the potential heart risks associated with these cancer therapies.

Gender

ALL

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.