Impedancemetry in Patients Monitored for Pulmonary Hypertension

NCT ID: NCT03673774

Last Updated: 2023-07-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-23
• Study Completion Date: 2021-01-01

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

Conditions

Pulmonary Hypertension

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

cardiac impedancemetry

Intervention Type: DEVICE

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

Interventions

cardiac impedancemetry

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

Intervention Type: 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elise Noel-Savina, MD

Role: PRINCIPAL_INVESTIGATOR

CHU of Toulouse

Locations

CHU TOULOUSE hospital larrey

Toulouse, Midi-Pyrennée, France

Countries

France

Other Identifiers

RC31/15/7849

Identifier Type: -

Identifier Source: org_study_id