Impedancemetry in Patients Monitored for Pulmonary Hypertension (HPepic)

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

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

Study Overview

• Status: Terminated
• Conditions: Pulmonary Hypertension
• Intervention / Treatment: Device: cardiac impedancemetry

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 Type: Interventional
• Enrollment (Actual): 59
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Midi-Pyrennée
    • Toulouse, Midi-Pyrennée, France, 31000
      • CHU Toulouse Hospital Larrey

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Elise Noel-Savina, MD, CHU of Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2017
• Primary Completion (Actual): January 1, 2021
• Study Completion (Actual): January 1, 2021

Study Registration Dates

• First Submitted: August 13, 2018
• First Submitted That Met QC Criteria: September 14, 2018
• First Posted (Actual): September 17, 2018

Study Record Updates

• Last Update Posted (Actual): July 12, 2023
• Last Update Submitted That Met QC Criteria: July 10, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: impedancemetry; pulmonary hypertension; cardiac output
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Hypertension, Pulmonary
• Other Study ID Numbers: RC31/15/7849

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No