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临床试验/NCT05920226
NCT05920226进行中(未招募)不适用

Myocardial Fibrosis in Patients With Permanent Pacemakers

Ryazan State Medical University1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2023年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
300
试验地点
1
主要终点
Changes in indicators of myocardial fibrosis

研究概览

简要总结

Patients with cardiac pathology and arrhythmias including those who have indications for pacemakers implantation will be included in the study. We will determine the influence of pacemaker implantation with the localization of the ventricular electrode in the top of the right ventricle or the middle third of the right ventricle according to echocardiographic and electrocardiographic parameters, congestive heart failure progression, patients' quality of life and follow-up therapy of patients with identified myocardial fibrosis with existing pacemaker.

Study of changes in echocardiography, electrocardiography, myocardial fibrosis markers, the quality of life of patients will allow to choose the most optimal localization of the ventricular electrode during implantation of the permanent pacemakers system in order to improve the quality of life of the patients.

详细描述

Anticipated design of the study: an open, prospective, study, with parallel groups of patients according to ICH GCP ((International Conference on Harmonisation - Good Clinical Practice) criteria.

The study will involve 300 patients with cardiac pathology and arrhythmias including those who have indications for pacemakers implantation, who will be allocated into 2 groups: group 1 - patients who require a permanent pacemaker placement; group 2 - patients who do not require a permanent pacemaker placement.

Patients involved in the study will undergo peripheral venous blood sampling to determine the level of myocardial fibrosis markers (Halitin-3, ST2), electrocardiography (assessment of the type of bradyarrhythmia, assessment of the presence/absence and type of intraventricular conductivity disorder, estimation of the width of the QRS complex, direction of the electric axis of the heart), echocardiography (evaluation of ejection fraction, heart chamber size, mitral and tricuspidal manifestation, interventricular delay), contrast-enhanced cardiac magnetic resonance imaging (MRI), quality of life assessment using the Aquarel questionnaire. All procedures will be repeated at time points as per protocol.

Specific information for Group A patients: there will be different variants of localization of the right ventricular lead (top of the right ventricle, the upper third of the ventricular septum, the middle third of the ventricular septum, the lower third of the ventricular septum, front wall of the right ventricle, lower wall of the right ventricle, parahisial region, His bundle). The analysis of the subgroups will be carried out according to the following criteria: electrode localization, main indication for pacemakers implantation, pacemakers model, type of initial intraventricular conductivity disorder.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
60 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • men or women over 60 years of age
  • . signed informed consent form
  • . presence of cardiac pathology and arrhythmia requiring pacemakers implantation (group A).
  • . presence of cardiac pathology and arrhythmia not requiring pacemaker implantation (group B).

排除标准

  • . active cancer or remission period less than 5 years;
  • . decompensated somatic pathology;
  • . active viral hepatitis, HIV or syphilis;
  • . men or women younger than 60 years of age or older than 85 years of age;
  • . withdrawn consent.

结局指标

主要结局

Changes in indicators of myocardial fibrosis

时间窗: June 2023 - June 2028

Changes in indicators of myocardial fibrosis in patients with cardiac arrhythmias depending on type of treatment

次要结局

  • Changes in echocardiography parameters(June 2023 - June 2028)
  • Changes in quality of life(June 2023 - June 2028)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Suchkov Igor A.

Professor

Ryazan State Medical University

研究点 (1)

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