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临床试验/NCT02066506
NCT02066506已完成不适用

Study of Adaptation of the Right Ventricle to Systemic Afterload

Assistance Publique - Hôpitaux de Paris2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2011年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
2
主要终点
fibrosis of systemic RV measured by MRI

研究概览

简要总结

the first purpose of the study is to determine the adaptative mechanisms of right ventricle (RV) to systemic afterload, and the mechanisms of RV failure, in patients with congenital heart disease and subaortic RV, using cardiac magnetic resonance imaging (CMR).The mechanisms are evaluated by measures of RV remodelling and RV wall stress using CMR. Second objectives are to evaluate these mechanisms using echography, arterial properties study and neurohormonal levels

详细描述

Right ventricle (RV) in sub-aortic position is a rare situation, mainly in two congenital heart defects: congenitally corrected transposition of the great arteries and complete transposition of the great arteries palliated by atrial switch. In these patients, increase of afterload leads to hypertrophy and late RV dilatation. The stress exercised on RV walls could play a role in adaptative mechanisms to systemic afterload. Beyond a remodelling threshold, it could cause fibrosis damage and RV systolic failure. Magnetic resonance imaging, which has a major potential in estimation of RV remodelling, wall stress and fibrosis, could shed light on RV adaptation to systemic afterload and evolution towards failure. Systemic RV remodelling and function could also depend on the neuro-hormone secretion and mechanical arterial properties, that have a direct influence on patients afterload. The first purpose of the study is to determine the adaptative mechanisms of RV to systemic afterload, and the mechanisms of RV failure, in patients with congenital heart disease and subaortic RV, using cardiac magnetic resonance imaging (CMR).The mechanisms are evaluated by measures of RV remodelling and RV wall stress using CMR. Second objectives are to evaluate these mechanisms using echography, arterial properties study and neurohormonal levels

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

fibrosis of systemic RV measured by MRI

时间窗: 48 months

remodelling indexes

时间窗: 48 months

wall stress index

时间窗: 48 months

次要结局

  • Arterial mechanical properties (stiffness aortic distensibility and arterial compliance)(48 months)
  • Rate of neurohormones of the renin-angiotensin-aldosterone system and neuropeptides(48 months)
  • Variability and reproducibility indices remodeling and wall stress MRI(48 months)
  • echographic measures of RV function and geometry indexes(48 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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