Impedancemetry in Patients Monitored for Pulmonary Hypertension

Pulmonary Hypertension Clinical Trial

— HPepic  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03673774
• Other study ID #: RC31/15/7849
• Status: Terminated
• Phase: N/A
• Start date: August 23, 2017
• Est. completion date: January 1, 2021

Study information

• Verified date: July 2023
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 59
• Est. completion date: January 1, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension

Intervention

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

Locations

Country	Name	City	State
France	CHU TOULOUSE hospital larrey	Toulouse	Midi-Pyrennée

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure of cardiac flow variation at 0 month by impedancemetry	The variation of cardiac flow is measured by impedancemetry at rest	0 month
Primary	Measure of cardiac flow variation at 6 month by impedancemetry	The variation of cardiac flow is measured by impedancemetry at rest	6 month
Secondary	Measure of cardiac flow variation during walking test	The variation of cardiac flow is measured by impedancemetry during walking test	0 month
Secondary	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
Secondary	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
Secondary	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
Secondary	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