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临床试验/NCT04116684
NCT04116684终止不适用

Digital Home Blood Pressure Monitoring in Type B Aortic Dissection Patients

The Cleveland Clinic2 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2019年9月23日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
4
试验地点
2
主要终点
Systolic Blood Pressure at End of 4 Weeks

研究概览

简要总结

The primary objective of this study is to determine the effectiveness of home digital blood pressure monitoring in aiding providers to maintain blood pressure within a therapeutic range in type B aortic dissection patients upon discharge from the hospital.

详细描述

Patients admitted to the Cleveland Clinic Main Campus with a diagnosis of type B aortic dissection or intramural hematoma who do not receive a surgical intervention during their index hospitalization, or planned intervention on follow up, and are discharged on medical therapy consisting of strict heart rate control and BP control will be included in the study. They will be either randomized to standard therapy to measure BP at home (standard of care) or intervention arm consisting of Withings Wireless Blood Pressure Monitor, which will transmit BP recordings from smartphone to MyChart/EPIC (test arm). All patients will first receive a 24 hour ambulatory monitor regardless of treatment assignment to establish baseline BP pattern. Following this patients randomized to intervention arm will utilize their Withings Blood Pressure Monitor. Providers on the study team will then adjust the patient's hypertensive medications to ensure their BP is below a systolic goal of 120 mmHg utilizing downloaded recordings available in the electronic medical record.

The primary clinical endpoint is the change in mean 24 hour systolic blood pressure between the start of the study and the end of the study period (4-week period). Secondary outcomes will include the number of patients able to achieve a therapeutic systolic blood pressure of 120 mmHg with both mean BP cuff and in office visit at end of 4 week period, increase in size as measured by computed tomography (CT) scan of the aorta, hospitalization or emergency room (ER) visits for symptoms from dissection or uncontrolled hypertension, hospitalization or ER visits for hypotension, all-cause mortality, and need for surgical intervention (open or endovascular).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
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

  • Patients discharged from Cleveland Clinic Main Campus with principal diagnosis of type B aortic dissection (defined as distal from left subclavian artery) who do not receive a surgical intervention during their hospitalization
  • Arm Circumference of 9-17 inches

排除标准

  • Patients who do not have a smart phone

结局指标

主要结局

Systolic Blood Pressure at End of 4 Weeks

时间窗: 4 weeks

Systolic Blood Pressure at end of 4 weeks as measured by 24 hour ambulatory cuff.

次要结局

  • Surgical Intervention(4 weeks)
  • Hospitalization or Emergency Room Visit for Uncontrolled Hypertension or Symptoms From Dissection(4 weeks)
  • Hospitalization or Emergency Room Visit for Hypotension(4 weeks)
  • Mortality(4 weeks)
  • Increase in Size or Progression of Dissection as Measured on Cardiac CT(4 weeks)
  • Questionnaire Describing Patient Experience in the Study(4 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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