Actively Recruiting
Natural History of Noncirrhotic Portal Hypertension
Led by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Updated on 2026-05-12
400
Participants Needed
1
Research Sites
736 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Background: \- Noncirrhotic Portal Hypertension (NCPH) is caused by liver diseases that increase pressure in the blood vessels of the liver. It seems to start slowly and not have many warning signs. Many people may not even know that they have a liver disease. There are no specific treatments for NCPH. Objectives: \- To learn more about how NCPH develops over time. Eligibility: \- People age 12 and older who have NCPH or are at risk for getting it. In the past year, they cannot have had other types of liver disease that typically result in cirrhosis, liver cancer, or active substance abuse. Design: * Participants will have 2 screening visits. * Visit 1: to see if they have or may develop NCPH. * Medical history * Physical exam * Urine and stool studies * Abdominal ultrasound * Fibroscan. Sound waves measure liver stiffness. \<TAB\>- Visit 2: * Blood tests * Abdominal MRI * Echocardiogram * Questionnaire * Liver blood vessel pressure (hepatic venous portal gradient (HVPG)) measurement. This is done with a small tube inserted in a neck vein. * They may have a liver biopsy. * All participants will visit the clinic every 6 months for a history, physical exam, and blood tests. They will also repeat some of the screening tests yearly. * Participants with NCPH will also have: * Upper endoscopy test. A tube inserted in the mouth goes through the esophagus and stomach. * At least every 2 years: Esophagogastroduodenoscopy. * At least every 4 years: testing including HVPG measurements and liver biopsy. * Participants without NCPH will also have: * Liver biopsy and HVPG measurements to see if they have NCPH. * Every 2 years: abdominal MRI and stool studies. * The study will last indefinitely.
CONDITIONS
Official Title
Natural History of Noncirrhotic Portal Hypertension
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older, including minors aged 12-17 years
- Women of childbearing potential must agree to use birth control unless menopausal or had hysterectomy
- Known diagnosis of NCPH or at risk due to underlying diseases such as CGD, SCD, Mastocytosis, CVID, CF, or CHF
You will not qualify if you...
- Pregnancy
- Other liver diseases that typically cause cirrhosis
- Active Chronic Hepatitis B infection with elevated virus levels
- Hepatitis C infection
- Other liver diseases like primary sclerosing cholangitis, primary biliary cirrhosis, Wilson's disease, or autoimmune hepatitis
- Hemochromatosis confirmed by biopsy or genetic testing
- Bile duct obstruction shown by recent imaging
- Cirrhosis confirmed by liver biopsy
- Active substance abuse within the past year
- Evidence of liver cancer or cholangiocarcinoma
- Any severe condition preventing study participation
- Inability to comply with study requirements or give informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
J
Jaha F Norman-Wheeler
CONTACT
T
Theo Heller, M.D.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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