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Impedancemetry in Patients Monitored for Pulmonary Hypertension (HPepic)

Primary Purpose

Pulmonary Hypertension

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
cardiac impedancemetry
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pulmonary Hypertension focused on measuring pulmonary hypertension, impedancemetry, cardiac output

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU TOULOUSE hospital larrey

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

cardiac impedancemetry

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Measure of cardiac flow variation during walking test
The variation of cardiac flow is measured by impedancemetry during walking test
Measure of cardiac flow variation during walking test at 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
Evaluate the correlation between measurement of capillary blood volume and measurement of cardiac flow by impedancemetry
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
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

Full Information

First Posted
August 13, 2018
Last Updated
July 10, 2023
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT03673774
Brief Title
Impedancemetry in Patients Monitored for Pulmonary Hypertension
Acronym
HPepic
Official Title
Prognostic Value of Cardiac Output Measured by Impedancemetry in Patients Monitored for Pulmonary Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Terminated
Why Stopped
RECRUITMENT ISSUES
Study Start Date
August 23, 2017 (Actual)
Primary Completion Date
January 1, 2021 (Actual)
Study Completion Date
January 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Hypertension
Keywords
pulmonary hypertension, impedancemetry, cardiac output

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
cardiac impedancemetry
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
cardiac impedancemetry
Intervention Description
The cardiac output is measured by impedance measurement at rest and during the walking test.
Primary Outcome Measure Information:
Title
Measure of cardiac flow variation at 0 month by impedancemetry
Description
The variation of cardiac flow is measured by impedancemetry at rest
Time Frame
0 month
Title
Measure of cardiac flow variation at 6 month by impedancemetry
Description
The variation of cardiac flow is measured by impedancemetry at rest
Time Frame
6 month
Secondary Outcome Measure Information:
Title
Measure of cardiac flow variation during walking test
Description
The variation of cardiac flow is measured by impedancemetry during walking test
Time Frame
0 month
Title
Measure of cardiac flow variation during walking test at 6 month
Description
The variation of cardiac flow is measured by impedancemetry during walking test
Time Frame
6 month
Title
Correlation between measurement of capillary blood volume and measurement of cardiac flow
Description
Evaluate the correlation between measurement of capillary blood volume and measurement of cardiac flow by impedancemetry
Time Frame
0 month
Title
Correlation between measurement of capillary blood volume and measurement of cardiac flow
Description
Evaluate the correlation between measurement of capillary blood volume and measurement of cardiac flow by impedancemetry
Time Frame
6 month
Title
Occurrence of an undesirable event
Description
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
Time Frame
18 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elise Noel-Savina, MD
Organizational Affiliation
CHU of Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU TOULOUSE hospital larrey
City
Toulouse
State/Province
Midi-Pyrennée
ZIP/Postal Code
31000
Country
France

12. IPD Sharing Statement

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Impedancemetry in Patients Monitored for Pulmonary Hypertension

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