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 @ 5:08 PM
Ignite Modification Date:
2025-12-24 @ 5:08 PM
NCT ID:
NCT02356250
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02356250
Study Brief:
Protocol Section:
NCT02356250