Impedancemetry in Patients Monitored for Pulmonary Hypertension

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

Detailed Description
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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

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

Conditions
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Pulmonary Hypertension

Intervention / Treatment
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* Device: cardiac impedancemetry


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cardiac impedancemetry<br>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. | Device: cardiac impedancemetry<br>* The cardiac output is measured by impedance measurement at rest and during the walking test.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of cardiac flow variation at 0 month by impedancemetry | The variation of cardiac flow is measured by impedancemetry at rest | 0 month | 
| Measure of cardiac flow variation at 6 month by impedancemetry | The variation of cardiac flow is measured by impedancemetry at rest | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of cardiac flow variation during walking test | The variation of cardiac flow is measured by impedancemetry during walking test | 0 month | 
| Measure of cardiac flow variation during walking test at 6 month | The variation of cardiac flow is measured by impedancemetry during walking test | 6 month | 
| Correlation between measurement of capillary blood volume and measurement of cardiac flow | Evaluate the correlation between measurement of capillary blood volume and measurement of cardiac flow by impedancemetry | 0 month | 
| Correlation between measurement of capillary blood volume and measurement of cardiac flow | Evaluate the correlation between measurement of capillary blood volume and measurement of cardiac flow by impedancemetry | 6 month | 
| Occurrence of an undesirable event | Collection of undesirable event like : - Deaths (all causes combined), Hospitalization for aggravation of PAH, Progression of the disease or decrease, Unsatisfactory long-term clinical response | 18 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pulmonary hypertension, impedancemetry, cardiac output