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临床试验/NCT07049289
NCT07049289进行中(未招募)不适用

Randomized Trial for Telemedical Support Versus Standard Treatment to Control Arterial Hypertension

Heart Center Leipzig - University Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年12月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
60
试验地点
1
主要终点
Time in blood pressure target range from randomization through 6 months

研究概览

简要总结

Prospective, randomized trial to assess the effects of a telemedical approach of antihypertensive treatment in comparison with standard care.

Total patient number: 60 patients.

  • Intervention group: biweekly telephone calls
  • Control group: standard of care

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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
否

入选标准

  • •Confirmed arterial hypertension with systolic or diastolic blood pressure >140/90 mmHg in standardized office blood pressure measurement
  • •Treatment with 1 to ≤4 antihypertensive drug classes
  • •Age >18 years
  • •Written informed consent

排除标准

  • •Participation in other randomized trials
  • •Patients under legal supervision or guardianship

研究组 & 干预措施

Control

No Intervention

Patients with arterial hypertension randomized to control arm with standard of care without additional interference through study team

Telemedical treatment

Experimental

Patients randomized to intervention group will receive biweeky telephone calls and adaption of antiyhpertensive medication if needed

干预措施: Telemonitoring (Other)

结局指标

主要结局

Time in blood pressure target range from randomization through 6 months

时间窗: 6 months

Time in target range of each blood pressure measurement in first 6 months between control and intervention group

次要结局

  • Time in target range months 6 to 12(6 months (7-12 months))
  • Medication adherence as assessed by blood/urine sampling after 6 and 12 months(0, 6 and 12 months)

研究者

发起方
Heart Center Leipzig - University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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