NCT02850692|Unknown
Portal Hypertension and Systemic Endothelial Function
ENDOTH-MUCO
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ENDOTH-MUCO
Sponsor study identifier
Secondary identifiers
OTHER · ANSM
interventional
60
1 country
1
Study Start
April 18, 2016
Actual (reported)Primary Completion
December 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Cystic fibrosis can affect organs other than the lungs. Liver disease affects about 30% of patients: its main manifestation is the development of portal hypertension (PHT). The pathophysiology of this comorbidity is still poorly understood. It was previously considered secondary to the formation of biliary cirrhosis but another hypothesis would be that of a primitive pathology of venous vessels may cause the gradual emergence of portal hypertension without cirrhosis. Evidence indiscutly suggest that cystic fibrosis is associated with a specific endothelial dysfunction, especially as the CFTR (Cystic Fibrosis Transmembrane conductance Regulator) protein is expressed on the surface of endothelial cells. The investigators hypothesize that liver disease related to PHT-associated cystic fibrosis is associated with systemic endothelial dysfunction. The aim is: To demonstrate a systemic endothelial dysfunction in patients with cystic fibrosis when associated with PHT. To study the correlations between measures of systemic endothelial function and serum markers of endothelial dysfunction and between measures of liver stiffness and systemic endothelial function.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 18, 2016
Actual (reported)June 16, 2016
Actual (reported)August 1, 2016
Actual (reported)December 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Endothelial systemic function measured by EndoPAT®
To compare the systemic endothelial function between the four study groups, the arterial tone index is measured by EndoPAT®. The EndoPAT® is the leading medical device for noninvasive endothelial function assessment. It quantifies the endothelium-mediated changes in vascular tone, elicited by a 5-minute occlusion of the brachial artery (using a standard blood pressure cuff). When the cuff is released, the surge of blood flow causes an endothelium-dependent. Flow Mediated Dilatation (FMD). The dilatation, manifested as Reactive Hyperemia, is captured by EndoPAT® as an increase in the PAT Signal amplitude. A post-occlusion to pre-occlusion ratio is calculated by the EndoPAT® software, providing the arterial tone index.
30 minutes
Serum levels of markers of endothelial dysfunction (tPA, thrombomodulin, Willebrandt factor, PAI1)
30 minutes
Endogline/Syndecan-4 ratio measurement
30 minutes
Measurement of hepatic elasticity by Fibroscan®
30 minutes
Hepatic abnormalities observed on injected abdominal CT.
30 minutes
Mucoviscidosis with portal hypertension. Blood sample (21ml). Hepatic elastography (Fibroscan®). Measure of endothelial function (Endopat®). Injected abdominal CT scan.
Mucoviscidosis without portal hypertension. Blood sample (21ml). Hepatic elastography (Fibroscan®). Measure of endothelial function (Endopat®). Injected abdominal CT scan.
Arterial tone index measured by EndoPAT®. Patient should neither eat nor drink at least 4 hours before exam and should neither smoke 3 hours before the exam.
Hopital Foch
Suresnes, 92150, France
Dominique Grenet, MD
Hopitral Foch
First Submitted
June 16, 2016
First Posted
August 1, 2016
Study Start
April 18, 2016
Actual (reported)Primary Completion
December 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
MR Imaging of Lung in the Follow-up Assessment of Cystic Fibrosis
Portal hypertension without Mucoviscidosis. Blood sample (21ml) . Hepatic elastography (Fibroscan®). Measure of endothelial function (Endopat®). Injected abdominal CT scan.
Healthy volunteers. Blood sample (21ml) . Hepatic elastography (Fibroscan®). Measure of endothelial function (Endopat®).
21 ml of blood to measure : hepatic workup, complete blood count (CBC), platelets, prothrombin time (PT), activated partial thromboplastin time (aPTT), C-reactive protein (CRP), lipid test, ionograms, creatinine, tissue plasminogen activator factor (tPA), plasminogen activator inhibitor-1 (PAI-1), tissue factor pathway inhibitor (TFPI), Willebrand factor, soluble thrombomodulin, blood levels of endoglin and syndecan. And level beta human chorionic gonadotropin (beta-HCG) for woman only.
Hepatic elastography by Fibrocan®. Patient should neither eat nor drink at least 2 hours before exam. 10 successive measurements are made.
Patient should neither eat nor drink at least 4 hours before exam. The examination is not realized if an abdominal scan or an MRI was performed in the five years prior to the day of the visit.
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Study Completion
December 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
May 26, 2020
Record last verified: 2020-05
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Source: ClinicalTrials.gov.
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