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临床试验/NCT03315429
NCT03315429Unknown不适用

Unmasking the Dynamic Component in Functional Mitral Regurgitation in Chronic Heart Failure

Medical University of Vienna2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2017年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
150
试验地点
2
主要终点
prevalence of severe dynamic FMR under stressed conditions

研究概览

简要总结

Background:

Chronic heart failure (HF) is frequently accompanied by functional mitral regurgitation (FMR) caused by left ventricular (LV) remodeling and subsequent papillary muscle displacement resulting in mitral valve (MV) leaflet tethering, dilatation and flattening of the mitral annulus and reduced closing forces. Up to moderate FMR affects the majority of patients with systolic heart failure - roughly 80% - still independently increasing mortality. Every fifth patient with chronic heart failure experiences a progression of FMR during the first three years of follow up despite guideline directed heart failure therapy, which is independently associated with a poor prognosis. Furthermore, MR is well known to have a strong dynamic component not only during the cardiac cycle at rest and with exercise.

Aims of the study:

The investigators therefore aim to assess whether stress tests in patients with functional mitral regurgitation unmasks significant dynamic mitral regurgitation or might aid to identify patients at risk of FMR progression in patients with functional mitral regurgitation in heart failure with reduced ejection fraction (HFrEF) under guideline directed medical therapy.

Study design:

The investigators will prospectively perform stress tests in all patients with non-severe FMR that are routinely seen in the heart failure outpatient clinic.

Study patients:

Patients with stable chronic heart failure on optimal medical therapy, who undergo routine ambulatory clinical control visits in the heart failure outpatient ward of the Medical University of Vienna, will be included in the present study. A written informed consent will be obtained before inclusion. Inclusion criteria will be a non-severe FMR, an age of at least 18 years and stable heart failure related medical therapy in the last 3 months.

Methods:

All patients that are willing to participate will undergo stress testing (i.e. volume challenge and low dose dobutamine stress) to determine whether patients display severe dynamic FMR under stress conditions. Within the registry patients will be followed-up during routine ambulatory visits for three years. Patients with severe dynamic functional mitral regurgitation will be compared to patients without severe dynamic FMR. Record of clinical events during the FUP will be performed. Routine laboratory parameters, have been measured at inclusion. Additionally, neurohormone patterns will be measured at baseline and at peak stress.

Sample size:

Expecting a prevalence of severe dynamic FMR of 20%, the investigators would include a total of 150 chronic heart failure patients taking also into account a study-dropouts of 20% ( loss of follow-up and mortality).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

  • non-severe FMR,
  • age of at least 18 years,
  • stable heart failure related medical therapy in the last 3 months.
  • Exclusion criteria
  • non-willing to participate
  • myocardial infarction,
  • cardiac decompensation within the last 3 months,
  • pregnancy,
  • life expectancy of less than 1 year for non cardiac reasons.

排除标准

  • 未提供

研究组 & 干预措施

Stress testing arm

Other

Stress testing of patients with functional mitral regurgitation.

干预措施: stress echocardiography (Diagnostic Test)

结局指标

主要结局

prevalence of severe dynamic FMR under stressed conditions

时间窗: 3 years

次要结局

  • correlation of the prevalence of dynamic FMR with the dynamic levels of neurohormones(3 years)
  • Establishment of an association between dynamic FMR and outcome (combined measure consisting of hospitalization for heart failure and/or death) during the follow-up period(3 years)
  • Identification of a relationship between dynamic FMR (defined as advance of at least one grade in severity with transition to at least moderate during stress) and FMR progression during rest within the 3 year follow-up period.(3 years)

研究者

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

Georg Goliasch

Asc.Prof. Priv.Doz. Dr., PhD

Medical University of Vienna

研究点 (2)

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