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Association Between Circulating BDNF Levels and Atrial Cardiomyopathy in Patients Undergoing Ablation for Persistent Atrial Fibrillation (METAPROFIL 2)

2026年6月10日 更新者:Centre Hospitalier Universitaire Dijon

trial fibrillation (AF) is the most common cardiac arrhythmia worldwide, and its prevalence continues to rise. AF is associated with serious complications, including embolic strokes, heart failure, and mortality. Characterized by rapid, irregular, and weakened contractions of the atria, AF is considered one of the "visible" electrophysiological manifestations of a broader condition known as atrial cardiomyopathy (ACM). Disruption of normal blood flow in the atrium, particularly in the context of an endocardium predisposed to thrombosis, predisposes to thrombus formation. Once dislodged from the atrial cavity and migrating to the cerebral arteries, these thrombi can cause a cardioembolic stroke. The main risk factors for ACI/AF are metabolic syndrome and aging. CMA is a condition that is difficult to diagnose because it is not clearly defined, except through histological analysis. Guided by the results of our experimental approaches, we aim to address this challenge by approaching CMA through one of its complications: persistent atrial fibrillation. Indeed, CMA can be assessed using electroanatomical mapping during atrial fibrillation ablation (AFA) procedures. During radiofrequency ablation of AF, electroanatomical mapping of the left atrium is performed to measure left atrial voltage, which serves as an indirect marker of the presence of atrial fibrosis, strongly associated with CMA. Other parameters relevant to the identification of CMA can be assessed during this procedure, such as conduction velocities and specific electrographic characteristics.

We plan to include 150 patients undergoing ablation for persistent atrial fibrillation at the Dijon Bourgogne University Hospital and to correlate circulating levels of BDNF (brain-derived neurotrophic factor) with electroanatomical mapping data of the left atrium. The electrical remodeling of the left atrium, including low-voltage areas and conduction velocity, as well as left atrial morphology assessed by pre-procedural cardiac computed tomography using the ADAS3 Galgo LA Module software, will be correlated with BDNF levels. Blood samples for BDNF assessment will be collected before or at the start of the ablation procedure, prior to any catheter insertion into the vessels.

While investigating the association between BDNF levels and CMA characteristics during AF ablation, thereby confirming the pathophysiological relationship with atrial remodeling, our objective is also to evaluate the prognostic role of BDNF levels in clinical and rhythm outcomes following AF ablation. Thus, we will compare changes in BDNF levels after AF ablation at one-year follow-up, correlating them with the evolution of CMA-based on left atrial parameters assessed by echocardiography or cardiac computed tomography-autonomic nervous system balance and heart rhythm obtained via Holter monitoring, as well as clinical outcomes.

研究概览

研究类型

观察性的

注册 (估计的)

150

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不适用

取样方法

概率样本

研究人群

Patients scheduled to undergo their first ablation procedure for persistent atrial fibrillation at the Dijon Bourgogne University Hospital.

描述

Inclusion Criteria:

  • Participants who have provided written consent
  • Patients aged 18 years or older.
  • Patients scheduled to undergo their first ablation procedure for persistent atrial fibrillation at the Dijon Bourgogne University Hospital

Exclusion Criteria:

  • A person who is not enrolled in or eligible for a social security program
  • A person subject to a legal protective measure (guardianship, conservatorship)
  • Person subject to a judicial safeguard measure
  • Pregnant or breastfeeding woman
  • Adult who is legally incapacitated or unable to give consent
  • Ablation of paroxysmal AF with or without electroanatomical mapping

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
Patients scheduled for ablation of persistent atrial fibrillation
Measurement of circulating BDNF levels via blood sample
Performing a cardiac CT scan to assess changes in atrial cardiomyopathy parameters

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
First recurrence of AF between 3 and 12 months following an initial ablation for persistent AF
大体时间:Between 3 and 12 months after the first AF ablation.
First recurrence of AF between 3 and 12 months following an initial ablation for persistent AF, defined as the first documented recurrence beyond the 3-month post-ablation blanking period, in accordance with the 2020 ESC and 2022 EHRA guidelines. The diagnosis is based on: (1) documentation of AF on a 12-lead ECG during an outpatient visit or hospitalization, or (2) documentation on a Holter ECG ≥ 24 hours performed routinely or for clinical reasons, or (3) any ambulatory rhythm recording documenting AF ≥ 30 seconds
Between 3 and 12 months after the first AF ablation.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年7月1日

初级完成 (估计的)

2029年7月1日

研究完成 (估计的)

2029年7月1日

研究注册日期

首次提交

2026年6月10日

首先提交符合 QC 标准的

2026年6月10日

首次发布 (实际的)

2026年6月15日

研究记录更新

最后更新发布 (实际的)

2026年6月15日

上次提交的符合 QC 标准的更新

2026年6月10日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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