跳至主要内容
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, Toulouse1 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
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
59
试验地点
1
主要终点
Measure of cardiac flow variation at 0 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
否

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

研究组 & 干预措施

cardiac impedancemetry

Experimental

Monocentric cohort study, prospective, evaluating the variability of cardiac output measurement by resting and stress impedancemetry as a prognostic factor for PH. Patients are included via the competence center of the PHP of the Midi Pyrenees region. The cardiac output is measured by impedance measurement at rest and during the walking test. The NO / CO coupled transfer measurement is performed at rest. The physician performing the consultation will not know the results of the IPC and these results will not influence the subsequent management.

The patient will be followed for 18 months as part of the research.

干预措施: cardiac impedancemetry (Device)

结局指标

主要结局

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

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

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)
  • Correlation between measurement of capillary blood volume and measurement of cardiac flow(0 month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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