A Pilot Study: Defining Peripheral Endothelial Function in Portal Hypertensive Cirrhotic Patients

NCT02356250 | Withdrawn

• 1 other identifier: CMC 14-0117-CTIL
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Rationale for the study: To 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. Aim: The 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.

Conditions

Portal Hypertension; Cirrhosis

Keywords

liver biopsy f 4

Outcome Measures

Primary Outcomes (1)

• 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)

  by measuring the PEF in every patient before evaluating his HVPG level in a hemodynamic study

  2 month for each patient and 1 year total

Study Arms (1)

PORTAL HYPERTENSION

PAIEBT WITH PORTAL HYPERTENSION

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

A maximum of 30 patients with cirrhosis Ages between 18 to 75

You may qualify if:

• \> 18 years old (Male/Female) and not more than 75 years old
• Diagnosis of cirrhosis:
• i. 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.
• c. Has been scheduled for hemodynamic study testing. d. Patients should have a Child Pugh score A or higher

You may not qualify if:

• Patients already receiving beta blockers
• Hepatocellular carcinoma
• Portal vein thrombosis
• Cholestatic liver disease
• Severe heart, pulmonary or renal disease.
• Patients with Ischemic heart disease
• Patients with diabetes mellitus
• Any major surgery in the past 3 months.
• Patient is a recipient of any organ transplant
• Patient, based on the opinion of the investigator, should not be enrolled into this study.
• Patients unable or unwilling to sign informed consent
• 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.
• Active smoking
• Uncontrolled hypertension
• Withdrawal criteria:

Sponsors & Collaborators

• Eyal Ashkenazi: lead

MeSH Terms

Conditions

Hypertension, Portal; Fibrosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• EYAL ASHKENAZI, DR

  Carmel Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: M.D

Study Record Dates

• First Submitted: January 25, 2015
• First Posted: February 5, 2015
• Study Start: February 18, 2015
• Primary Completion: November 29, 2016
• Study Completion: November 29, 2016
• Last Updated: July 26, 2018

Record last verified: 2018-07