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临床试验/NCT03673774
NCT03673774终止不适用

Prognostic Value of Cardiac Output Measured by Impedancemetry in Patients Monitored for Pulmonary Hypertension

University Hospital, Toulouse2 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2017年8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
59
试验地点
2
主要终点
Measure of cardiac flow variation at 6 month by impedancemetry

研究概览

简要总结

Monocentric cohort study, prospective, evaluating the variability of cardiac output measurement by resting and stress impedancemetry as a prognostic factor for Pulmonary Hypertension

详细描述

Cardiac impedancemetry is a technique that allows an electrical representation of cardiac flows. To do this, 6 electrodes are applied to the thorax and a low intensity and high frequency electrical current is transmitted. The impedance is recorded and the variations of the impedance represent the changes in intra-thoracic volume and thus the volume of systolic ejection. This measurement can be done at rest but also during exercise during the walking test. A test of the NO / CO coupled transfer measurement is also performed.

The devices that will be used in this project are the Physio-Flow® system and Masterscreen NO / CO coupled transfer measurement device

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient over 18 years and under 80 years
  • Patients who have been diagnosed with PAH (group 1 PH according to the Nice 2013 classification) or post-embolic pulmonary hypertension (group 4 PH) under medical treatment;
  • HTP incident or prevalent less than 6 months
  • Patient coming for follow-up or emergency consultation or hospitalization with a clinical examination and a walking test
  • Patient affiliated to a health insurance scheme
  • Patient having signed informed consent

排除标准

  • Subjects under juridical protections or tutelage measure
  • pregnant or lactating woman
  • pulmonary hypertension du to cardiac pathology, chronic respiratory disease, or uncertain determinism.
  • pulmonary hypertension of group 4 treated surgically or endoscopically.
  • pulmonary hypertension incident or prevail for 6 months or more
  • contraindication to impedancemetry
  • inability to perform a walking test

结局指标

主要结局

Measure of cardiac flow variation at 6 month by impedancemetry

时间窗: 6 month

The variation of cardiac flow is measured by impedancemetry at rest

Measure of cardiac flow variation at 0 month by impedancemetry

时间窗: 0 month

The variation of cardiac flow is measured by impedancemetry at rest

次要结局

  • Measure of cardiac flow variation during walking test at 6 month(6 month)
  • Correlation between measurement of capillary blood volume and measurement of cardiac flow(6 month)
  • Occurrence of an undesirable event(18 month)
  • Measure of cardiac flow variation during walking test(0 month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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