Clinical trial NCT03673774: Impedancemetry in Patients Monitored for Pulmonary Hypertension
Official title: Prognostic Value of Cardiac Output Measured by Impedancemetry in Patients Monitored for Pulmonary Hypertension
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pulmonary Hypertension
Keywords: pulmonary hypertension
impedancemetry
cardiac output
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2018-09-17
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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

Eligibility criteria: 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

Primary outcomes:
measure: Measure of cardiac flow variation at 0 month by impedancemetry
timeFrame: 0 month
measure: Measure of cardiac flow variation at 6 month by impedancemetry
timeFrame: 6 month
Secondary outcomes:
measure: Measure of cardiac flow variation during walking test
timeFrame: 0 month
measure: Measure of cardiac flow variation during walking test at 6 month
timeFrame: 6 month
measure: Correlation between measurement of capillary blood volume and measurement of cardiac flow
timeFrame: 0 month
measure: Correlation between measurement of capillary blood volume and measurement of cardiac flow
timeFrame: 6 month
measure: Occurrence of an undesirable event
timeFrame: 18 month
Other outcomes:
Locations:
city: Toulouse
country: France
facility: CHU TOULOUSE hospital larrey
state: Midi-Pyrennée
Study officials:
affiliation: CHU of Toulouse
name: Elise Noel-Savina, MD
role: PRINCIPAL_INVESTIGATOR
References: