Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:28 PM
Ignite Modification Date:
2025-12-24 @ 3:28 PM
NCT ID:
NCT02850692
Eligibility 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 β-human chorionic gonadotropin (β-HCG) urine test is negative;
* Patient unable to provide written consent. Patient under guardianship.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02850692
Study Brief:
Protocol Section:
NCT02850692