RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-03-01
Study Completion:2027-04-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05724121

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 110 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Currently receiving or planning to receive a BTKi or venetoclax.
  2. 2. Male or female, aged 18 or older
  3. 3. Stated willingness to comply with all study procedures and availability for the duration of the study
  4. 4. Ability of subject to understand and the willingness to sign a written informed consent document
  1. 1. Any acute cardiac condition including myocardial infarction or decompensated heart failure within the past 3 months
  2. 2. Pregnancy or lactation- use of BTK inhibitors is contraindicated in pregnant or nursing individuals.

Contacts and Locations

Study Contact

Ingrid C Frey
CONTACT
(301) 402-0797
ingrid.frey@nih.gov
Christine E Gruessner, M.D.
CONTACT
(240) 550-6022
christine.gruessner@nih.gov

Principal Investigator

Christine E Gruessner, M.D.
PRINCIPAL_INVESTIGATOR
National Heart, Lung, and Blood Institute (NHLBI)

Study Locations (Sites)

National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
United States

Collaborators and Investigators

Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

  • Christine E Gruessner, M.D., PRINCIPAL_INVESTIGATOR, National Heart, Lung, and Blood Institute (NHLBI)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-01
Study Completion Date2027-04-08

Study Record Updates

Study Start Date2023-03-01
Study Completion Date2027-04-08

Terms related to this study

Keywords Provided by Researchers

  • SUDDEN CARDIAC DEATH
  • Chronic Lymphocytic Leukemia (CLL)
  • Ibrutinib Treatment
  • Atrial Fibrillation/Flutter
  • Ventricular Arrhythmias
  • Natural History

Additional Relevant MeSH Terms

  • Chronic Lymphocytic Leukemia (CLL)
  • Waldenstr(SqrRoot)(Delta)m s Macroglobulinemia
  • Mantle Cell Lymphoma
  • Sudden Cardiac Death
  • Cardiac Arrhythmias
  • Hematologic Malignancies