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临床试验/NCT07272395
NCT07272395招募中不适用

Monitoring Right Ventricular Function in Patients Undergoing Implantable Cardiac Electronic Device (CIED) Therapy: A Multimodal Imaging and Biomarker-Based Approach

Istanbul University - Cerrahpasa1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年8月15日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
40
试验地点
1
主要终点
Change in Right Ventricular Ejection Fraction (RVEF) by Cardiac MRI

研究概览

简要总结

This study aims to understand how the right side of the heart changes in people who receive an implantable cardiac electronic device (CIED), such as a pacemaker, ICD, or CRT device. The right ventricle (RV) can sometimes be affected after these devices are placed, but the reasons and timing are not well understood.

To investigate this, we will examine participants at two time-points: before their device is implanted and again six months later. At each visit, we will assess heart function using echocardiography, a non-contrast cardiac MRI scan, and an ultrasound score of venous congestion called the VEXUS score. We will also take a small blood sample to measure a biomarker called FGF-23, which may reflect changes in heart function.

The study does not involve any experimental treatment, and all implanted devices are part of routine medical care. The imaging tests and blood samples are for research purposes only. By comparing the measurements before and after device implantation, we hope to better understand how CIEDs influence right-sided heart function and whether imaging findings are related to changes in blood biomarkers.

详细描述

Right ventricular (RV) dysfunction and tricuspid valve changes are increasingly recognised in patients who receive implantable cardiac electronic devices (CIEDs). Potential mechanisms include lead-leaflet interaction, pacing-related alterations in RV mechanics and changes in venous haemodynamics. However, prospective data integrating advanced imaging, ultrasound-based congestion assessment and circulating biomarkers remain limited.

This prospective observational cohort study will evaluate RV structure and function at two predefined time-points: immediately before CIED implantation and at six months after implantation. Assessments will include (1) transthoracic echocardiography with quantitative RV parameters, (2) a standardised VEXUS ultrasound score for systemic venous congestion, (3) non-contrast cardiac magnetic resonance (CMR) imaging for RV volumetry and tissue characterisation and (4) plasma measurement of FGF-23 as a biomarker potentially associated with RV remodelling.

All implanted devices are clinically indicated and form part of routine care; no experimental device or therapeutic intervention is used. Imaging and blood sampling performed for the study are non-interventional and carry minimal risk. The purpose of the study is to quantify changes in RV size and function over six months and to explore whether alterations in imaging findings correspond to changes in venous congestion or biomarker levels. The results may help identify patients at risk of adverse RV remodelling following CIED implantation.

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Change in Right Ventricular Ejection Fraction (RVEF) by Cardiac MRI

时间窗: Baseline (pre-implantation) to 6 months post-implantation

RVEF will be quantified using non-contrast 1.5T cardiac MRI cine imaging. The primary endpoint is the absolute change in RVEF between pre-implantation and 6-month follow-up.

Change in Tricuspid Regurgitation Severity

时间窗: Baseline to 6 months

Tricuspid regurgitation will be graded (none, mild, moderate, severe) using echocardiography and confirmed by CMR-derived regurgitant volume.

次要结局

  • Change in Right Ventricular End-Diastolic Volume (RVEDV) by Cardiac MRI(Baseline to 6 months)
  • Change in VEXUS Score(Baseline to 6 months)
  • Change in Right Ventricular Longitudinal Strain (RV-FWLS)(Baseline to 6 months)
  • Change in BNP Concentration(Baseline to 6 months)
  • Change in Plasma FGF-23 Concentration(Baseline to 6 months)
  • Lead-related Tricuspid Valve Interaction(6 months)

研究者

发起方
Istanbul University - Cerrahpasa
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sahra Asena Balcioglu

Resident Physician, Cardiology Department

Istanbul University - Cerrahpasa

研究点 (1)

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