Thoracic Bio-reactance Measurement of Cardiac Output in Pulmonary Hypertension (PHREACT)
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|ClinicalTrials.gov Identifier: NCT03890627|
Recruitment Status : Not yet recruiting
First Posted : March 26, 2019
Last Update Posted : March 26, 2019
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|
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|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|
|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.
- 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.
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
|Contact: Ségolène TURQUIER, Dr||04.72.35.73.32 ext +firstname.lastname@example.org|
|Contact: Jean-François MORNEX, Pr||04.27.85.77.00 ext +33||jean-françois.email@example.com|
|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 firstname.lastname@example.org|
|Contact: Jean-François MORNEX, Pr 04.27.85.77.00 ext +33 jean-françois.email@example.com|
|Principal Investigator: Ségolène TURQUIER, Dr|
|Sub-Investigator: Jean-François MORNEX, Pr|
|Sub-Investigator: Kais AHMAD, Dr|
|Sub-Investigator: Julie TRACLET, Dr|