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Étude observationnelle des arythmies cardiaques chez des sujets traités avec des inhibiteurs de BTK

28 octobre 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Description détaillée

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

Type d'étude

Observationnel

Inscription (Estimé)

135

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Nom: Christine E Gruessner, M.D.
Numéro de téléphone: (240) 550-6022
E-mail: christine.gruessner@nih.gov

Sauvegarde des contacts de l'étude

Nom: Ingrid C Frey
Numéro de téléphone: (301) 402-0797
E-mail: ingrid.frey@nih.gov

Lieux d'étude

États-Unis
- Maryland
  - Bethesda, Maryland, États-Unis, 20892
    - Recrutement
    - National Institutes of Health Clinical Center
    - Contact:
      
      NIH Clinical Center Office of Patient Recruitment (OPR)
      
      Numéro de téléphone: TTY dial 711 800-411-1222
      
      E-mail: ccopr@nih.gov

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 110 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon de probabilité

Population étudiée

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)

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Modèles d'observation: CASE_CONTROL
Perspectives temporelles: PROSPECTIVE

Nombre de groupes / cohortes

Cohortes et interventions

Groupe / Cohorte
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

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats	Description de la mesure	Délai
arrhythmogenic cardiac effects of BTKi and sudden death within the first 12 months of BTKi therapy Délai: 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

Mesures de résultats secondaires

Mesure des résultats	Description de la mesure	Délai
tests for identifying and monitoring cardiac arrhythmias in patients receiving BTKi Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

National Heart, Lung, and Blood Institute (NHLBI)

Les enquêteurs

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

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Liens utiles

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

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 mars 2023

Achèvement primaire (Estimé)

8 avril 2027

Achèvement de l'étude (Estimé)

8 avril 2027

Dates d'inscription aux études

Première soumission

10 février 2023

Première soumission répondant aux critères de contrôle qualité