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临床试验/NCT01281241
NCT01281241Unknown不适用

The Connection Between Mechanical Alternans Measured by Pressure-Volume (PV) Loop Catheter in Patients With Ischemic Heart Failure and the Occurrence of Microvolt T Wave Alternans (MTWA)

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2010年9月最近更新:
适应症

试验速览

阶段
不适用
入组人数
10
试验地点
1
主要终点
Presence or absence of mechanical alternans and MTWA

研究概览

简要总结

The main objective is to investigate mechanical alternans and MTWA in patients with heart failure caused by coronary artery disease to demonstrate a possible correlation between these two phenomena.

详细描述

In patients with severe heart failure and aortic valve disease mechanical alternans or pulsus alternans (a condition in which there is a beat-to-beat oscillation in the strength of cardiac muscle at a constant heart rate) is observed.

The mechanisms linking mechanical to electrophysiological dysfunction in heart failure are still under investigation, but impaired calcium cycling is the most striking abnormality of failing myocytes, and is most responsible for contractile dysfunction. Yet it remains unclear how this influences susceptibility to arrhythmias.

The MTWA is suggested as a risk marker to identify high risk patients for potential VTEs but the underlying mechanism is not completely understood. The aim of this study is to investigate this in a clinical setting by measuring LV parameters using a PV loop conductance catheter and generate TWA recording simultaneously to demonstrate a possible correlation between these two phenomena in patients with ischemic heart failure and find out if MTWA could turn into a more valuable risk factor.

Our hypothesis is that alternating changes in LV filling explains the electrocardiogenesis of TWA by changing the position of the heart relative to the body surface electrodes in an alternating way.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with heart failure caused by coronary artery disease
  • Indication for left ventricular radiofrequency (LV RF) ablation
  • LVEF ≤ 35% measured by echocardiogram or MRI

排除标准

  • hemodynamically instable patients
  • age under 18 and over 85 years,
  • heart failure not caused by coronary artery disease
  • Severe co-morbidity

结局指标

主要结局

Presence or absence of mechanical alternans and MTWA

时间窗: 1 year

次要结局

  • The occurrence of ventricular tachyarrhythmic events.(1 year)
  • Differences in reduced or more preserved LVEF and the occurrence of the two phenomena(1 year)
  • Influence of LV compliance on arrhythmogenesis of the infarction border zone.(1 year)

研究者

研究点 (1)

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