Portal Hypertension and Systemic Endothelial Function

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02850692
• Date of registration: 16/06/2016
• Prospective Registration: No
• Primary sponsor: Hopital Foch
• Public title: Portal Hypertension and Systemic Endothelial Function ENDOTH-MUCO
• Scientific title: Portal Hypertension and Systemic Endothelial Function: Investigation of Systemic Endothelial Dysfunction in Case of Portal Hypertension Associated With Cystic Fibrosis.
• Date of first enrolment: April 18, 2016
• Target sample size: 60
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02850692
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

France

Contacts

• Name: Dominique Grenet, MD

• Name: Dominique Grenet, MD

• Name: Dominique Grenet, MD
• Affiliation: Hopitral Foch

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients over 18 years.

- Patients affiliated to a social security scheme

- Patients who have given their written consent

- Four study groups:

- Group A: Patients with cystic fibrosis (CF) with liver damage and diagnosis of CF is
based on sweat test and genetic analysis). PHT diagnosis is based on tomographic
criteria portal vein width superior to> 15 mm, portosystemic shunt and / or
splenomegaly

- Group B: cystic fibrosis patients without PHT diagnosis is based on sweat test and
genetic analysis). Absence of PHTP is predicated on tomographic of Scanner.

- Group C: Patients free of CF with PHT related to another cause. Patients followed for
viral liver disease (hepatitis B or C) or idiopathic portal venous system disorder,
with or without cirrhosis. The diagnosis of PHT is based on tomographic criteria
portal vein width superior to> 15 mm, highlighting porto-systemic shunt, splenomegaly)
and / or indirect signs namely ascitis or esophageal varices.

- Group D: Healthy controls.

Exclusion Criteria:

- Patients suffering from uncontrolled hypertension despite treatment (systolic BP> 160
mmHg);

- Patient with uncontrolled diabetes (glycated Hb measurement done during the last 3
months > 7%);

- Patients with uncorrected dyslipidemia;

- Patient suffering from a sleep apnea syndrome;

- Patients with severe coagulation disorders: PR< 50%, platelets < 30,000 / microL,
current anticoagulant treatment;

- Patient with contra-indication to the injection of iodinated contrast material,
including history of hypersensitivity to iodinated contrast media or renal clearance
failure <50 ml / min Modification of Diet in Renal Disease (MDRD) formula

- Patients allergic to latex which contra-indicates endothelial function measurement;

- Acute pathology unresolved at the time of inclusion: respiratory exacerbation, ongoing
infection, recent thrombosis;

- Smoking history> 10 pack-years;

- Vasoactive therapy that may interfere with the measurement of endothelial function and
cannot be stopped 24 hours before the measurement: nitrates, beta-blockers,
angiotensin converting enzyme inhibitors, calcium channel blockers, inhibitors of
endothelin receptors, similar prostacyclin analog, inhibitors of phosphodiesterases;

- Pregnant and lactating women (all patients with childbearing potential will only be
included if their ß-human chorionic gonadotropin (ß-HCG) urine test is negative;

- Patient unable to provide written consent. Patient under guardianship.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Portal Hypertension

Cystic Fibrosis

Intervention(s)

Biological: Blood sample

Diagnostic Test: Injected abdominal CT

Other: Hepatic elastography

Other: measure of endothelial function

Primary Outcome(s)

Endothelial systemic function measured by EndoPAT® [Time Frame: 30 minutes]

Secondary Outcome(s)

Endogline/Syndecan-4 ratio measurement [Time Frame: 30 minutes]

Serum levels of markers of endothelial dysfunction (tPA, thrombomodulin, Willebrandt factor, PAI1) [Time Frame: 30 minutes]

Measurement of hepatic elasticity by Fibroscan® [Time Frame: 30 minutes]

Hepatic abnormalities observed on injected abdominal CT. [Time Frame: 30 minutes]

Secondary ID(s)

2015-A01872-47

2015/33

Source(s) of Monetary Support

Please refer to primary and secondary sponsors