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

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 110
Healthy Volunteers: f
View:

⁃ To be eligible to participate in this study, an individual must meet all of the following criteria:

• Currently receiving or planning to receive a BTKi or venetoclax.

• Male or female, aged 18 or older

• Stated willingness to comply with all study procedures and availability for the duration of the study

• Ability of subject to understand and the willingness to sign a written informed consent document

Locations
United States
Maryland
National Institutes of Health Clinical Center
RECRUITING
Bethesda
Contact Information
Primary
Ingrid C Frey
ingrid.frey@nih.gov
(301) 312-0765
Backup
Christine E Gruessner, M.D.
christine.gruessner@nih.gov
(240) 550-6022
Time Frame
Start Date: 2023-03-01
Estimated Completion Date: 2027-04-08
Participants
Target number of participants: 135
Treatments
Cohort A
includes all patients prior to starting therapy with a BTKi
Cohort B
includes all patients already on therapy with a BTKi
Cohort C
includes all patients prior to starting therapy with venetoclax
Sponsors
Leads: National Heart, Lung, and Blood Institute (NHLBI)

This content was sourced from clinicaltrials.gov