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Observationeel onderzoek naar hartritmestoornissen bij proefpersonen die werden behandeld met BTK-remmers

28 oktober 2026 bijgewerkt door: National Heart, Lung, and Blood Institute (NHLBI)

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.

Studie Overzicht

Toestand

Werving

Conditie

Gedetailleerde beschrijving

Study Description:

Pharmacologic therapy with BTK inhibitors (BTKi) is associated with an increased risk of cardiac arrhythmias which can lead to sudden death. There is currently no standard for cardiac screening or monitoring patients on BTKi. We hypothesize that thorough and routine comprehensive cardiac evaluations prior to starting therapy with BTKi and repeated during therapy with BTKi will result in earlier identification of cardiac arrhythmias with the goal of minimizing associated morbidity and mortality. In addition, venetoclax, a different standard therapy for chronic lymphocytic leukemia, has not been associated with increased cardiac adverse events and could serve as a control group.

Objectives:

Primary objective: Identify, monitor, and analyze the arrhythmogenic effects of BTKi as well as sudden death

Secondary objective: Assess the utility of different cardiac tests for identifying and monitoring cardiac arrhythmias in patients receiving BTKi or venetoclax

Exploratory objective: To examine the relationship between the development of cardiac arrhythmias in patients on BTKi as it relates to other variables

Endpoints:

Primary endpoint:

-A composite endpoint of clinically significant cardiac arrhythmias and sudden death in patients starting a BTKi (Cohort A) and in patients already receiving BTKi (Cohort B).

Secondary endpoints:

Detection of arrhythmias on devices (rest/stress EKG, ambulatory EKG monitor, KardiaMobile)
Arrhythmia (treatment emergent or worsening) in patients on BTKi
Sudden death in patients on BTKi
A composite endpoint of clinically significant cardiac arrhythmias and sudden death in patients starting venetoclax
Difference in cardiac arrhythmias and sudden death between different BTKi groups (e.g., ibrutinib vs. non-ibrutinib group)
Difference in cardiac arrhythmias and sudden death between BTKi and venetoclax groups

Exploratory endpoints:

Pharmacokinetic levels of BTKi
Duration of BTKi exposure
Cumulative BTKi dose
Genetic variants
Cardiac structural remodeling
Medical comorbidities
Concomitant medications
Substance use
Identify risk factors or biomarkers for arrhythmia

Studietype

Observationeel

Inschrijving (Geschat)

135

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Naam: Christine E Gruessner, M.D.
Telefoonnummer: (240) 550-6022
E-mail: christine.gruessner@nih.gov

Studie Contact Back-up

Naam: Ingrid C Frey
Telefoonnummer: (301) 402-0797
E-mail: ingrid.frey@nih.gov

Studie Locaties

Verenigde Staten
- Maryland
  - Bethesda, Maryland, Verenigde Staten, 20892
    - Werving
    - National Institutes of Health Clinical Center
    - Contact:
      
      NIH Clinical Center Office of Patient Recruitment (OPR)
      
      Telefoonnummer: TTY dial 711 800-411-1222
      
      E-mail: ccopr@nih.gov

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 110 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Kanssteekproef

Studie Bevolking

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)

Beschrijving

INCLUSION CRITERIA:

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

EXCLUSION CRITERIA:

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Observatiemodellen: CASE_CONTROL
Tijdsperspectieven: PROSPECTIVE

Aantal groepen / cohorten

Cohorten en interventies

Groep / Cohort
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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
arrhythmogenic cardiac effects of BTKi and sudden death within the first 12 months of BTKi therapy Tijdsspanne: 12 months	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

Secundaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
tests for identifying and monitoring cardiac arrhythmias in patients receiving BTKi Tijdsspanne: 36 months	-Detection of arrhythmias on devices (rest EKG, stress EKG, ambulatory EKG monitor, KardiaMobile) -Clinically significant and other arrhythmias (treatment emergent or worsening) in patients on BTKi and on venetoclax -Sudden death -Composite endpoint of clinically significant cardiac arrhythmias and sudden death in patients starting venetoclax -Differences in cardiac arrhythmias and sudden death within BTKi (e.g., ibrutinib vs. non-ibrutinib group) -Differences in cardiac arrhythmias and sudden death between patients on BTKi and venetoclax	36 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Onderzoekers

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

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Nuttige links

<p>NIH Clinical Center Detailed Web Page</p>

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 maart 2023

Primaire voltooiing (Geschat)

8 april 2027

Studie voltooiing (Geschat)

8 april 2027

Studieregistratiedata

Eerst ingediend

10 februari 2023

Eerst ingediend dat voldeed aan de QC-criteria