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Thoracic Bio-reactance Measurement of Cardiac Output in Pulmonary Hypertension (PHREACT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03890627
Recruitment Status : Not yet recruiting
First Posted : March 26, 2019
Last Update Posted : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:

Pulmonary Hypertension (PH) is a rare disease characterized by an increase in pulmonary vascular resistance, leading to a progressive decline in cardiac output (CO).Since cardiac output is correlated with the prognosis of the disease, the conduct of a right heart catheterization (thermodilution measurement, reference technique) during the annual follow-up visit of patients in competences centres is recommended. In practice, it is not systematically performed because of it is invasive, with potential risk for the patient, and there is limited logistical capacity for its implementation. The estimation of cardiac output is thus often based on cardiac ultrasound but its measurement is potentially biased.

Starling ™ SV is a non-invasive cardiac output monitor based on thoracic bio-reactance measurement. Several clinical studies have shown that cardiac output measured by bio-reactance is strongly correlated with the measurement obtained by catheterization in different indications. Rich et al. (2013) assessed bio-reactance specifically in 50 patients with Pulmonary Hypertension compared with thermodilution. The results showed that the measurement of cardiac output by bio-reactance was feasible in these patients, had a better accuracy than by catheterization, and was reliable for detecting changes in cardiac output after a vasodilatation test.

The Starling ™ SV monitor could thus have a place in the follow-up of patients who are being treated for Pulmonary Hypertension. Since it is a rapid, non-invasive examination, it could be performed on an outpatient basis, especially as a first-line test to check the stability of the CO, thus avoiding the systematic use of right heart catheterization, which would then be reserved only to patients for whom the measurement by bio-reactance would show a decrease of cardiac output compared to the previous value. Before being able to propose this use in current practice, it is necessary to carry out a pilot study which will make it possible to explore the interest of bio-reactance in this situation.


Condition or disease Intervention/treatment
Pulmonary Hypertension Device: Thoracic bio-reactance

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Interest of Cardiac Output Measurement by Thoracic Bio-reactance for Monitoring of Patients Treated for a Pulmonary Hypertension
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Thoracic bio-reactance measurement of cardiac output Device: Thoracic bio-reactance
Cardiac output variation measured by thoracic bio-reactance, between inclusion and one year after hemodynamic evaluation by right cardiac catheterization, to discriminate stable patients from those that degrade.




Primary Outcome Measures :
  1. Ability of the relative variation of cardiac output measured by thoracic bio-reactance to predict the patient's status (stable or unstable). [ Time Frame: 12 months ]
    A patient will be considered unstable if the decrease in the relative variation of cardiac output measured with thermodilution between visit one and one year after visit one is at least 15%. Then, the ability of the relative variation of cardiac output measured by thoracic bio-reactance to predict the patient's status (stable or unstable) will be assessed.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients with pulmonary hypertension and followed by a Competence Center.
Criteria

Inclusion Criteria:

  • Aged over 18
  • Presenting pulmonary hypertension (PH) followed by the Competence Center of the Hospices Civils de Lyon
  • Follow-up for pulmonary hypertension groups 1, 4 or 5
  • Of which the cardiac index is ≥ 2,5 L/min/m²
  • Expressing its non-opposition to the participation of this study
  • Benefiting from a social security scheme or similar

Exclusion Criteria:

  • Adult patient protected by Law
  • Patient for whom a thermodilution measurement of cardiac output (CO) is unreliable: right-left shunt; or uncorrected congenital heart disease; or variability> 10% of the 3 measurements of CO obtained by thermodilution
  • pulmonary hypertension groups 2 or 3
  • Hemodynamic aggravation since the previous visit: increased pressure or decreased cardiac index

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03890627


Contacts
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Contact: Ségolène TURQUIER, Dr 04.72.35.73.32 ext +33 segolene.turquier@chu-lyon.fr
Contact: Jean-François MORNEX, Pr 04.27.85.77.00 ext +33 jean-françois.mornex@chu-lyon.fr

Locations
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France
Service d'Explorations Fonctionnelles Respiratoires, centre de compétences de l'hypertension pulmonaire Hospices Civils de Lyon, Groupement Hospitalier Est
Bron, France, 69677
Contact: Ségolène TURQUIER, Dr    04.72.35.73.32 ext +33    segolene.turquier@chu-lyon.fr   
Contact: Jean-François MORNEX, Pr    04.27.85.77.00 ext +33    jean-françois.mornex@chu-lyon.fr   
Principal Investigator: Ségolène TURQUIER, Dr         
Sub-Investigator: Jean-François MORNEX, Pr         
Sub-Investigator: Kais AHMAD, Dr         
Sub-Investigator: Julie TRACLET, Dr         
Sponsors and Collaborators
Hospices Civils de Lyon
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03890627    
Other Study ID Numbers: 69HCL18_0819
First Posted: March 26, 2019    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases