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临床试验/NCT00883610
NCT00883610已完成不适用

Modulation of QT Interval by Rapid Atrial Pacing in Patients With Dual Chamber Pacemakers

Vanderbilt University1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2009年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
12
试验地点
1
主要终点
Determine the effect of abrupt changes in atrial rate on QT intervals

研究概览

简要总结

The purpose of this study is to learn what effect rapid atrial pacing (in patients with dual chamber pacemakers) will have on the electrocardiogram including the QT Interval. The investigators are also interested in the differences caused by genes.

详细描述

This study requires a total of two study days as well as two follow up visits. During study day one, baseline blood will be drawn, a baseline electrocardiogram will be performed, and continuous QT Interval monitoring will be performed. The pacemaker rate will be increased to 90bpm at different time intervals and additional blood will be drawn to measure the effects of these rates changes.

On study day two, baseline blood will be drawn, a urine specimen will be obtained, an electrocardiogram will be performed, and continuous QT Interval monitoring will be performed. Following the acquisition of this information, the pacemaker rate will be decreased to 80bpm. We will obtain blood specimens, a urine specimen and an electrocardiogram at 30 minutes post rate change and again at 60 minutes post rate change.

Two days following the rate decrease to 80bpm, the patient will return to clinic to have their rate decreased to 70bpm. In two more days, the patient will return for a final rate change to 60bpm.

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

入选标准

  • Must be at least 21 years old
  • Must have a dual chamber pacemaker implanted more than three months ago
  • Must be followed by the Vanderbilt University Medical Center's Arrhythmia Device Clinic
  • The indication for the pacemaker must not be related to coronary artery disease (CAD) or congestive heart failure (CHF)

排除标准

  • Cannot be pacemaker dependent
  • History of ventricular arrhythmias and/or implantable defibrillators (ICDs)
  • History of paroxysmal, persistent, or permanent atrial fibrillation (AF)
  • Congenital long QT syndrome
  • History of coronary artery disease
  • History of, or currently receiving, treatment for congestive heart failure
  • Unable to tolerate dual-chamber pacing (DDD) at 90 bpm due to palpitations, chest pain, shortness of breath, lightheadedness, dizziness, or presyncope
  • Pregnant women
  • Any patient without specific documentation of an echocardiogram negative for CHF (systolic or diastolic dysfunction)within five years prior to study enrollment
  • Any patient without specific documentation of an objective diagnostic test to rule out CAD within five years prior to study enrollment

结局指标

主要结局

Determine the effect of abrupt changes in atrial rate on QT intervals

时间窗: 7 days

次要结局

未报告次要终点

研究者

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

Dawood Darbar

Associate Professor of Medicine and Clinical Pharmacology

Vanderbilt University

研究点 (1)

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