Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

Estudo Observacional de Arritmias Cardíacas em Indivíduos Tratados com Inibidores de BTK

28 de outubro de 2026 atualizado por: 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.

Visão geral do estudo

Status

Recrutamento

Condições

Descrição detalhada

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

Tipo de estudo

Observacional

Inscrição (Estimado)

135

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Nome: Christine E Gruessner, M.D.
Número de telefone: (240) 550-6022
E-mail: christine.gruessner@nih.gov

Estude backup de contato

Nome: Ingrid C Frey
Número de telefone: (301) 402-0797
E-mail: ingrid.frey@nih.gov

Locais de estudo

Estados Unidos
- Maryland
  - Bethesda, Maryland, Estados Unidos, 20892
    - Recrutamento
    - National Institutes of Health Clinical Center
    - Contato:
      
      NIH Clinical Center Office of Patient Recruitment (OPR)
      
      Número de telefone: TTY dial 711 800-411-1222
      
      E-mail: ccopr@nih.gov

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 110 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra de Probabilidade

População do estudo

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)

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Modelos de observação: CASE_CONTROL
Perspectivas de Tempo: PROSPECTIVE

Número de grupos/coortes

Coortes e Intervenções

Grupo / Coorte
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

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado	Descrição da medida	Prazo
arrhythmogenic cardiac effects of BTKi and sudden death within the first 12 months of BTKi therapy Prazo: 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

Medidas de resultados secundários

Medida de resultado	Descrição da medida	Prazo
tests for identifying and monitoring cardiac arrhythmias in patients receiving BTKi Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

National Heart, Lung, and Blood Institute (NHLBI)

Investigadores

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

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Links úteis

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

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de março de 2023

Conclusão Primária (Estimado)

8 de abril de 2027

Conclusão do estudo (Estimado)

8 de abril de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

10 de fevereiro de 2023

Enviado pela primeira vez que atendeu aos critérios de CQ