Impedancemetry in Patients Monitored for Pulmonary Hypertension

Not Applicable

Terminated

• Conditions: Pulmonary Hypertension

• Registration Number: NCT03673774
• Lead Sponsor: University Hospital, Toulouse

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

Study Timeline

• Study Start: 2017-08-23
• Study First Submitted: 2018-08-13
• Study First Submitted QC: 2018-09-14
• Study First Posted: 2018-09-17
• Primary Completion: 2021-01-01
• Study Completion: 2021-01-01
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-10
• Last Update Posted: 2023-07-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 59

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Measure of cardiac flow variation at 6 month by impedancemetry	6 month	The variation of cardiac flow is measured by impedancemetry at rest
Measure of cardiac flow variation at 0 month by impedancemetry	0 month	The variation of cardiac flow is measured by impedancemetry at rest

Secondary Outcome Measures

Name	Time	Method
Measure of cardiac flow variation during walking test at 6 month	6 month	The variation of cardiac flow is measured by impedancemetry during walking test
Correlation between measurement of capillary blood volume and measurement of cardiac flow	6 month	Evaluate the correlation between measurement of capillary blood volume and measurement of cardiac flow by impedancemetry
Occurrence of an undesirable event	18 month	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
Measure of cardiac flow variation during walking test	0 month	The variation of cardiac flow is measured by impedancemetry during walking test

Trial Locations

Locations (1)

CHU TOULOUSE hospital larrey; 🇫🇷 Toulouse, Midi-Pyrennée, France