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Impedancemetry in Patients Monitored for Pulmonary Hypertension

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03673774
Acronym
HPepic
Enrollment
59
Registered
2018-09-17
Start date
2017-08-23
Completion date
2021-01-01
Last updated
2023-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Hypertension

Keywords

pulmonary hypertension, impedancemetry, cardiac output

Brief summary

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

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

Interventions

DEVICEcardiac impedancemetry

The cardiac output is measured by impedance measurement at rest and during the walking test.

Sponsors

University Hospital, Toulouse
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Measure of cardiac flow variation at 0 month by impedancemetry0 monthThe variation of cardiac flow is measured by impedancemetry at rest
Measure of cardiac flow variation at 6 month by impedancemetry6 monthThe variation of cardiac flow is measured by impedancemetry at rest

Secondary

MeasureTime frameDescription
Measure of cardiac flow variation during walking test0 monthThe variation of cardiac flow is measured by impedancemetry during walking test
Measure of cardiac flow variation during walking test at 6 month6 monthThe variation of cardiac flow is measured by impedancemetry during walking test
Correlation between measurement of capillary blood volume and measurement of cardiac flow0 monthEvaluate the correlation between measurement of capillary blood volume and measurement of cardiac flow by impedancemetry
Occurrence of an undesirable event18 monthCollection of undesirable event like : - Deaths (all causes combined), Hospitalization for aggravation of PAH, Progression of the disease or decrease, Unsatisfactory long-term clinical response

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026