T-Wave Alternans in Dialysis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Measure the degree of cardiac electrical instability at various times in the dialysis cycle.
研究概览
简要总结
Sudden cardiac death due to arrhythmia is the leading cause of death in end-stage renal disease (ESRD) patients treated with hemodialysis (HD). As it is anticipated that the number of individuals with ESRD will exceed 1.2 million in the next 20 years, sudden death in this population has enormous public health impact. Research has shown that arrhythmic events are temporally associated with longer periods between HD with a three-fold risk of events in the 12 hours preceding the longest inter-dialysis interval. The exact cause of these findings is unknown.
详细描述
The purpose of this study is to assess the degree of cardiac electrical instability at various times in the dialysis cycle. The hypothesis is that longer time intervals between hemodialysis results in sympathetic and electrolyte-induced alterations in ventricular repolarization that can be measured non-invasively using microvolt T-wave alternans (TWA). This increase in cardiac electrical instability may serve as a link between the clinically observed periods of increased risk and the occurrence of sudden cardiac death.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with chronic ESRD who have been on HD for at least 3 months
- •Subjects 18 to 90 years of age with one or more risk factors for coronary artery disease or sudden cardiac death, including diabetes, peripheral vascular disease, known coronary artery disease, or ejection fraction < 40% by any imaging modality.
排除标准
- •Subjects unwilling or unable to give written informed consent.
- •Patients unable to return for regularly scheduled dialysis treatments
- •Atrial fibrillation or flutter at screening
- •Major surgical procedure two months prior to enrollment
- •High grade heart block or a permanent pacemaker in situ
- •Patients with known allergies to adhesive tape
结局指标
主要结局
Measure the degree of cardiac electrical instability at various times in the dialysis cycle.
时间窗: Basline, during dialysis
次要结局
未报告次要终点
研究者
Rod Passman
Principal Investigator
Northwestern University