Impedancemetry in Patients Monitored for Pulmonary Hypertension

NCT03673774 | Terminated

• 1 other identifier: RC31/15/7849
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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

Conditions

Pulmonary Hypertension

Keywords

pulmonary hypertension; impedancemetry; cardiac output

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Measure of cardiac flow variation during walking test

  0 month

• Measure of cardiac flow variation during walking test at 6 month

  6 month

• Correlation between measurement of capillary blood volume and measurement of cardiac flow

  0 month

• Correlation between measurement of capillary blood volume and measurement of cardiac flow

  6 month

• Occurrence of an undesirable event

  18 month

Study Arms (1)

cardiac impedancemetry

EXPERIMENTAL

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

Interventions

cardiac impedancemetry DEVICE

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

cardiac impedancemetry

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

CHU TOULOUSE hospital larrey

Toulouse, Midi-Pyrennée, 31000, France

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Elise Noel-Savina, MD

  CHU of Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2018
• First Posted: September 17, 2018
• Study Start: August 23, 2017
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: July 12, 2023

Record last verified: 2023-07

Locations

FR (1)