跳至主要内容
临床试验/NCT02382484
NCT02382484已完成不适用

Impact of Pacing Site and AV Delay on Blood Pressure in Hypertensive Patients: An Acute Study in Patients Undergoing an Electrophysiology Study or Pacemaker Implant

BackBeat Medical Inc1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2011年3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
19
试验地点
1
主要终点
Change of blood pressure upon initiation of pacing with AV delays of 20 ms

研究概览

简要总结

The purpose of this study is to test whether the A-V sequential pacing strategy shown to effectively reduce blood pressure in a dog model of hypertension also reduces blood pressure acutely in patients with hypertension (systolic blood pressure greater than 140 mmHg) despite medical treatments.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
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

  • Patient has hypertension with systolic blood pressure >140 mmHg despite at least one antihypertensive medication.
  • Patient has a clinical indication for a pacemaker or an electrophysiology study involving introduction of transvenous electrophysiology catheters to the right atrium and/or right ventricle.
  • Patient is willing and able to provide informed consent

排除标准

  • Patient is in atrial fibrillation at the time of the study
  • Patient has an ejection fraction less than 45%
  • Patient has a history of symptomatic heart failure, regardless of EF
  • Patient is undergoing an ablation procedure for a bypass track (WPW)
  • Patient has a history of resuscitation from ventricular fibrillation or sustained ventricular tachycardia

结局指标

主要结局

Change of blood pressure upon initiation of pacing with AV delays of 20 ms

时间窗: Approx. 5 minutes after initiating pacing with the respective AV delay

Change of blood pressure upon initiation of pacing with AV delays of 80 ms

时间窗: Approx. 5 minutes after initiating pacing with the respective AV delay

Assessment of any adverse effects

时间窗: Over a 24 hour period following the acute tests

Change of blood pressure upon initiation of pacing with AV delays of 40 ms

时间窗: Approx. 5 minutes after initiating pacing with the respective AV delay

Change of blood pressure upon initiation of pacing with AV delays of 2 ms

时间窗: Approx. 5 minutes after initiating pacing with the respective AV delay

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验