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临床试验/NCT07592481
NCT07592481尚未招募不适用

Connected Blood Pressure Monitoring in Patients With Hematologic Malignancies Initiating Covalent BTK Inhibitors

Centre Hospitalier de la côte Basque0 个研究点目标入组 40 人开始时间: 2026年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
40

研究概览

简要总结

This pilot prospective study aims to evaluate adherence to home blood pressure monitoring using connected blood pressure (BP) devices in patients with malignant B-cell hemopathies initiating covalent Bruton tyrosine kinase inhibitors (cBTKi). The objective is to determine whether digital BP monitoring improves early detection and management of BTKi-induced hypertension over 6 months.

详细描述

Scientific justification:

Oral anticancer therapies, including cBTKi such as ibrutinib, acalabrutinib, and zanubrutinib, have transformed the treatment of various lymphoid malignancies. However, BTKi are associated with a high incidence of hypertension, reported in 20-70% of cases. Early and reliable detection is essential to avoid cardiovascular toxicity and prevent therapy discontinuation. In clinic blood pressure assessments are often limited by white-coat effect and lack of reproducibility, whereas home BP monitoring improves diagnostic accuracy and patient engagement. Despite this, there is no standardized BP monitoring strategy for patients with cBTKi.

Intervention/strategy description:

All participants will receive a validated connected blood pressure monitor and standardized training on appropriate measurement procedures. BP values will be automatically transmitted to a secure platform monitored daily by an Advanced Practice Nurse (IPA), who will ensure adherence, verify data quality, and coordinate clinical interventions when necessary.

Follow-up description:

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥18 years
  • Diagnosis of lymphoid malignancy: chronic lymphocytic leukemia, follicular lymphoma, marginal zone lymphoma, lymphoplasmacytic lymphoma, Waldenström macroglobulinemia, or mantle cell lymphoma
  • Initiation of oral BTK inhibitor therapy (ibrutinib, acalabrutinib, or zanubrutinib), in treatment-naive or relapsed patients
  • Affiliation with a social security system
  • Signed written informed consent

排除标准

  • Known cognitive impairment
  • No internet access
  • Individuals under guardianship, curatorship, or legal protection

研究组 & 干预措施

Connected home blood pressure monitoring with daily IPA supervision

Experimental

干预措施: Connected home blood pressure monitoring with daily IPA supervision. (Device)

研究者

发起方
Centre Hospitalier de la côte Basque
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mme BEAU Vanessa

Study nurse

Centre Hospitalier de la côte Basque

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