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

Cirrhosis Clinical Trial

Official title:

A Pilot Study: Defining Peripheral Endothelial Function in Portal Hypertensive

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02356250
• Other study ID #: CMC 14-0117-CTIL
• Status: Withdrawn
• Start date: February 18, 2015
• Est. completion date: November 29, 2016

Study information

• Verified date: July 2018
• Source: Carmel Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 29, 2016
• Est. primary completion date: November 29, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cirrhosis
• Hypertension, Portal
• Portal Hypertension

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eyal Ashkenazi

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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