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临床试验/NCT02459626
NCT02459626已完成不适用

Comparison of Non-invasive Assessment of Cardiac Fibrosis by MRI Derived T1-Mapping and Ventricular Intrinsic Diastolic Function by Pressure-volume-analysis in Patients With Heart Failure With Preserved Ejection Fraction

Heart Center Leipzig - University Hospital1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2014年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
36
试验地点
1
主要终点
Correlation of extracellular volume (MRI) and myocardial stiffness (p-v-loops)

研究概览

简要总结

StiffMAP-HFpEF trial is an investigator initiated, observational, single-center study that will evaluate whether fibrosis quantification by cardiac MRI correlates with left and right ventricular stiffness derived from pressure-volume analysis, aiming to clarify if cardiac MRI is a valid, non-invasive method to assess diastolic function in patients with Heart Failure with preserved ejection fraction.

详细描述

Heart Failure with preserved ejection fraction (HFpEF) and diastolic dysfunction is a growing medical challenge. To date almost every second patient with heart failure has a preserved ejection fraction and recent data show that outcomes in these patients are as bad as in those with reduced ejection fraction. In clinical routine the diagnosis of HFpEF is complicated by indirect assessment of diastolic function. Mechanistically the diastolic dysfunction is among others believed to be caused by the development of diffuse myocardial fibrosis with an increase of extracellular matrix.

Direct assessment of the intrinsic diastolic function and stiffness of the ventricle can be obtained by pressure-volume-curve tracings through a conductance catheter. Although this offers the benefit of assessing load-dependent and load-independent parameters of diastolic function as well as information on contractility and ventricular-arterial coupling, the use of this technique is limited by its invasiveness in daily care.

Newer MRI techniques have made it possible to quantify not only local fibrosis but also diffuse fibrosis (i.e. T1-Mapping) and determine extracellular volumes.

Moreover, the role of right ventricular function is in HFpEF is not well defined.

Aim of the current study is therefore to evaluate the role of MRI in assessing cardiac fibrosis in the context of impaired LV diastolic function in HFpEF patients, as well as to evaluate the role of systolic and diastolic right ventricular functional impairment in this patient cohort.

研究设计

研究类型
Observational
观察模型
Case Control
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

  • LV-EF > 50%
  • Indication for invasive cardiac catheterization

排除标准

  • know CAD or CAD in Angiography (stenoses > 50%)
  • acute coronary syndromes
  • Cerebral ischemia within the last year
  • contraindications for MRI
  • more than mild valvular disease
  • Constrictive pericarditis, restrictive Cardiomyopathy, pericardial effusion
  • pregnancy
  • enrolment in other study

结局指标

主要结局

Correlation of extracellular volume (MRI) and myocardial stiffness (p-v-loops)

时间窗: Baseline

次要结局

  • Change in endiastolic pressure volume relation (EDPVR) under excercise between groups(Baseline)
  • LV stiffness constant (ß) between groups(Baseline)
  • Time constant of LV-relaxation (Ƭ) between groups(Baseline)
  • Right Ventricular Endsystolic Elastance Slope(Baseline)
  • Right Ventricular Endsystolic Stiffness Constant(Baseline)

研究者

发起方
Heart Center Leipzig - University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Philipp Lurz

Clinical Investigator, Professor, Managing Senior Physician

Heart Center Leipzig - University Hospital

研究点 (1)

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