An observational study in Pulmonary Hypertension, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-10-13.
Sponsored by Hospices Civils de Lyon · Observational
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.
1,105 studies on the registry are indexed under Hypertension, Pulmonary; 234 are open to participants now.
This study's enrollment of 60 is below the median of 116 across 386 observational studies indexed under Hypertension, Pulmonary.
Browse Hypertension, Pulmonary studies →Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult patients with pulmonary hypertension and followed by a Competence Center.
Exclusion Criteria:
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).
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.
Time frame: 12 months
Plan to share: No
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This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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Hospices Civils de Lyon