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

NCT05724121 | Recruiting

• 2 other identifiers: 10000923000923-H
• Study Type: observational
• Target: 135
• Locations: 1 country
• Sites: 1

Brief 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. ...

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• arrhythmogenic cardiac effects of BTKi and sudden death within the first 12 months of BTKi therapy

  1\. Clinically significant cardiac arrhythmias while on a BTKi (treatment emergent in those without a history of arrhythmias and worsening of arrhythmia for those with an arrhythmia at the time of enrollment testing) within 12 months. For Cohort A, if a patient has an arrhythmia at the time of baseline testing, only worsening or new arrhythmias will be called an event. For Cohort B, all arrhythmias will be called an event. 2. Sudden death

  12 months

Secondary Outcomes (1)

• tests for identifying and monitoring cardiac arrhythmias in patients receiving BTKi

  36 months

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Sample size of 135 subjects including men and women over 18 years old followed at the NIH Clinical Center who are either about to start a BTKi (Cohort A) or venetoclax (Cohort C) as well as those already taking BTKi (Cohort B)

You may qualify if:

• 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

You may not qualify if:

• An individual who meets any of the following criteria will be excluded from participation in this study:
• Any acute cardiac condition including myocardial infarction or decompensated heart failure within the past 3 months
• Pregnancy or lactation- use of BTK inhibitors is contraindicated in pregnant or nursing individuals.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, Mantle-Cell; Death, Sudden, Cardiac; Arrhythmias, Cardiac; Hematologic Neoplasms; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma, Non-Hodgkin; Lymphoma; Heart Arrest; Heart Diseases; Cardiovascular Diseases; Death, Sudden; Death; Neoplasms by Site

Study Officials

• Christine E Gruessner, M.D.

  National Heart, Lung, and Blood Institute (NHLBI)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ingrid C Frey

CONTACT

(301) 402-0797; ingrid.frey@nih.gov

Christine E Gruessner, M.D.

CONTACT

(240) 550-6022; christine.gruessner@nih.gov

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2023
• First Posted: February 13, 2023
• Study Start: March 1, 2023
• Primary Completion (Estimated): April 8, 2027
• Study Completion (Estimated): April 8, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-02-05

Locations

US (1)