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临床试验/NCT03978676
NCT03978676已完成不适用

Exercise-induced in Secondary Mitral Regurgitation: Analysis of Echocardiographic Parameters at Rest Predicting the Onset of Significant Exercise-induced Mitral Regurgitation

Fondation Hôpital Saint-Joseph1 个研究点 分布在 1 个国家目标入组 87 人开始时间: 2019年7月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
87
试验地点
1
主要终点
Aggravation of secondary mitral insuffiency

研究概览

简要总结

Secondary mitral insufficiency is a common complication of heart failure, aggravating symptoms and prognosis, and may be responsible for worsening dyspnea, pulmonary edema, and excess mortality. It is essentially a ventricular rather than a valvular disease, whose origin may be ischemic or not. It is induced by a geometrical and contractile modification of the left ventricle which causes an imbalance between the tensile and the closing forces of the mitral valve thus causing a defect of coaptation and the increase of the surface between the mitral leaves and the ring in systole (tenting). Dynamic mitral insufficiency is defined by changes in the degree of severity of regurgitation as a function of hemodynamic conditions.

During exercise, the course of mitral insufficiency is variable and is not predicted by the degree of regurgitation at rest. The worsening of the leak is also well correlated with the onset of dyspnea on exertion in patients with left Ventricular Ejection Fraction heart failure (LVEF reduced). Nevertheless, there is little data available in the literature on the factors predisposing to the development of stress-related mitral insufficiency, as well as its clinical and echocardiographic impact in the cardiac insufficiency patient, particularly in the case of preserved LVEF (6.7%).

The identification of echocardiographic data at rest to predict and anticipate the behavior of mitral insufficiency in the effort (aggravation or stability / disappearance), would allow a simplified evaluation and a better management in this population of patients for which the evaluation in echography of effort can be technically complex and limited (difficulty of quantification of the mitral leak, time of effort sometimes too short ...).

研究设计

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

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

  • Patient whose age is ≥ 18 years
  • Patient who received a stress echocardiography performed by an experienced operator in the evaluation of mitral insufficiency at the Paris Saint-Joseph Hospital Group between March 2016 and February 2019
  • Patient presenting during this ultrasound a mitral insufficiency secondary to rest and effort
  • Francophone patient

排除标准

  • Patients under guardianship or curatorship
  • Patients deprived of their liberty
  • Patients who oppose the use of their data for this research
  • Patient with primary mitral insufficiency, structural abnormality of valvular leaflets
  • Patient with valvular or valvular calcification
  • Patient with other significant associated valvulopathy (grade> II / IV: corresponds to the severity of mitral leak quantified on cardiac ultrasound)
  • Patient with cardiac valve prosthesis
  • Hypertrophic or restrictive cardiomyopathy
  • Patient with congenital heart disease

结局指标

主要结局

Aggravation of secondary mitral insuffiency

时间窗: Day 1

Il will measure an increase of the ORS of more than 0.5 cm² in case of IM Grade 4 at rest.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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