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

NCT ID: NCT02356250

Last Updated: 2018-07-26

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-02-18
• Study Completion Date: 2016-11-29

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.

Detailed Description

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

Conditions

Portal Hypertension; Cirrhosis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

PORTAL HYPERTENSION

PAIEBT WITH PORTAL HYPERTENSION

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. > 18 years old (Male/Female) and not more than 75 years old

2. 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

Exclusion Criteria

1. Patients already receiving beta blockers

2. Hepatocellular carcinoma

3. Portal vein thrombosis

4. Cholestatic liver disease

5. Severe heart, pulmonary or renal disease.

6. Patients with Ischemic heart disease

7. Patients with diabetes mellitus

8. Any major surgery in the past 3 months.

9. Patient is a recipient of any organ transplant

10. Patient, based on the opinion of the investigator, should not be enrolled into this study.

11. Patients unable or unwilling to sign informed consent

12. 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.

13. Active smoking

14. Uncontrolled hypertension

Withdrawal criteria:

1. Patient that based on the opinion of the investigator should be withdrawl from the study due to no compliance

2. Patient wish to stop participate in study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eyal Ashkenazi

OTHER

Sponsor Role: lead

Responsible Party

Eyal Ashkenazi

M.D

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

EYAL ASHKENAZI, DR

Role: PRINCIPAL_INVESTIGATOR

Carmel Medical Center

Other Identifiers

CMC 14-0117-CTIL

Identifier Type: -

Identifier Source: org_study_id