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临床试验/NCT00970476
NCT00970476撤回不适用

Response To Cardiac Resynchronization Therapy In Heart Failure: Role Of Arterial Stiffness

Creighton University0 个研究点开始时间: 2007年1月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
If arterial stiffness can predict the response to resynchronization therapy in heart failure.

研究概览

简要总结

To determine if arterial stiffness as measured by non-invasive pulse wave velocity can predict the response to resynchronization therapy in heart failure.

详细描述

The patients receiving CRT are medically refractory, symptomatic, NYHA class III or IV disease and QRS duration of 130 m sec or greater, and a left ventricular ejection fraction of 30 percent or less.

The pulse wave velocity between carotid and femoral (PWVcf) will be recorded in each subject at base line (before and after CRT), at one month (after AV delay optimization) and again at 6 months after CRT. The arterial pulse wave is recorded at a proximal artery, such as the carotid artery, and as well as at a distal artery, such as the femoral artery. The superficial location of the carotid and femoral arteries means that their pulse waveforms are readily measured noninvasively using the M Hz Doppler probe, and between these two sites the pulse wave has to travel through most of the aorta. The time delay between the arrival of a predefined part of the pulse wave, such as the foot, at these 2 points is obtained by gating to the peak of the R-wave of the ECG. The distance traveled by the pulse wave is measured over the body surface and PWV is then calculated as distance/time (m/s).

Clinical evidence of response: Either one or more of the following: 1) Improvement in NYHA functional classification, 2) Improvement in 6 minute walking distance. 3) Change in functional class, exercise tolerance while the heart is getting smaller on CXR. 4) Stabilization of patient CHF even without subjective improvement over 6 months (remaining class III rather than progressive to class IV). Imaging evidence of response: 1) Increase in left ventricular ejection fraction. 2) Reduction of mitral regurgitation. 3) Reduction of LV volume signifying reverse remodeling.

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
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The patients receiving CRT are medically refractory, symptomatic, NYHA class III or IV disease and QRS duration of 130 m sec or greater, and a left ventricular ejection fraction of 30 percent or less.
  • All individuals are carefully selected after appropriate clinical evaluation as determined by the treating physicians to exclude possible reversible causes of heart failure.

排除标准

  • Patients with permanent atrial fibrillation and non-palpable carotid and/or femoral pulses will be excluded due to technical limitations of the procedure used for the measurement of arterial stiffness.

结局指标

主要结局

If arterial stiffness can predict the response to resynchronization therapy in heart failure.

时间窗: 6 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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