Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2026-01-29 @ 1:22 PM
Study NCT ID:
NCT02356250
Status:
WITHDRAWN
Last Update Posted:
2018-07-26
First Post:
2015-01-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pilot Study: Defining Peripheral Endothelial Function in Portal Hypertensive Cirrhotic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006975', 'term': 'Hypertension, Portal'}, {'id': 'D005355', 'term': 'Fibrosis'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'no participants enrolled', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2015-02-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2016-11-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-24', 'studyFirstSubmitDate': '2015-01-25', 'studyFirstSubmitQcDate': '2015-02-04', 'lastUpdatePostDateStruct': {'date': '2018-07-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-02-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'is to try and characterize the peripheral endothelial function (PEF) in patient with cirrhosis and CSPH (by measuring the PEF in every patient before evaluating his HVPG level in a hemodynamic study)', 'timeFrame': '2 month for each patient and 1 year total', 'description': 'by measuring the PEF in every patient before evaluating his HVPG level in a hemodynamic study'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['liver biopsy f 4'], 'conditions': ['Portal Hypertension', 'Cirrhosis']}, 'descriptionModule': {'briefSummary': 'Rationale for the study:\n\nTo try and define PEF in cirrhotic patients with CSPH, and maybe to try to find a correlation between HVPG ( hepatic vein pressure gradient ) result and PEF result in a way that the result of the PEF test will be able to predict if a patient has CSPH (yes of no). By this, to try and develop a portable office-based device that can produce immediate results in a non-invasive manner in cirrhotic patients and help in evaluating prognosis in these patients in a noninvasive manner.\n\nAim:\n\nThe aim of this study is to try and characterize the peripheral endothelial function (PEF) in patient with cirrhosis and CSPH. This will be evaluated by measuring the PEF in every patient before evaluating his HVPG level in a hemodynamic study.', 'detailedDescription': 'To try and define PEF in cirrhotic patients with CSPH, and maybe to try to find a correlation between HVPG result and PEF result in a way that the result of the PEF test will be able to predict if a patient has CSPH (yes of no). By this, to try and develop a portable office-based device that can produce immediate results in a non-invasive manner in cirrhotic patients and help in evaluating prognosis in these patients in a noninvasive manner'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'A maximum of 30 patients with cirrhosis Ages between 18 to 75', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. \\> 18 years old (Male/Female) and not more than 75 years old\n2. Diagnosis of cirrhosis:\n\ni. By liver biopsy ii. Or strong suspicion of cirrhosis by accepted criteria for the clinical diagnosis of cirrhosis (e.g. peripheral edema or varices, palpable hard left lobe of the liver, small right lobe span or palpable splenomegaly), and/or radiological evidence of cirrhosis (by abdominal US, CT, or MRI, showing a nodular liver and/or portosystemic collaterals with portal vein patency and/or ascites and/or splenomegaly, and/or colloid shift on a colloid-isotope liver-spleen scan), and/or laboratory variables (platelets \\<100,000/mm3, albumin\\< 3.5g/dL, or INR \\>1.3) and/or presence of esophageal varices (without previous variceal bleeding episode) or HVPG≥12mmHg from previous testing, or by FIbroscan or Fibrotest results showing fibrosis stage- 4.\n\nc. Has been scheduled for hemodynamic study testing. d. Patients should have a Child Pugh score A or higher\n\nExclusion Criteria:\n\n1. Patients already receiving beta blockers\n2. Hepatocellular carcinoma\n3. Portal vein thrombosis\n4. Cholestatic liver disease\n5. Severe heart, pulmonary or renal disease.\n6. Patients with Ischemic heart disease\n7. Patients with diabetes mellitus\n8. Any major surgery in the past 3 months.\n9. Patient is a recipient of any organ transplant\n10. Patient, based on the opinion of the investigator, should not be enrolled into this study.\n11. Patients unable or unwilling to sign informed consent\n12. Patients that are participating in other clinical trials evaluating experimental treatments or procedures or have participated in a clinical trial in the past 3 months.\n13. Active smoking\n14. Uncontrolled hypertension\n\nWithdrawal criteria:\n\n1. Patient that based on the opinion of the investigator should be withdrawl from the study due to no compliance\n2. Patient wish to stop participate in study.'}, 'identificationModule': {'nctId': 'NCT02356250', 'briefTitle': 'A Pilot Study: Defining Peripheral Endothelial Function in Portal Hypertensive Cirrhotic Patients', 'organization': {'class': 'OTHER', 'fullName': 'Carmel Medical Center'}, 'officialTitle': 'A Pilot Study: Defining Peripheral Endothelial Function in Portal Hypertensive', 'orgStudyIdInfo': {'id': 'CMC 14-0117-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PORTAL HYPERTENSION', 'description': 'PAIEBT WITH PORTAL HYPERTENSION'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'EYAL ASHKENAZI, DR', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Carmel Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eyal Ashkenazi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'M.D', 'investigatorFullName': 'Eyal Ashkenazi', 'investigatorAffiliation': 'Carmel Medical Center'}}}}