Idiopathic portal hypertension.
S K Sarin, S R Aggarwal
https://pubmed.ncbi.nlm.nih.gov/9693222Actively Recruiting
Age: 12Years - 100Years
All Genders
ID02417740
Natural History of Noncirrhotic Portal Hypertension Study to Understand Disease Progression and Biomarkers
Led by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Updated on 2026-06-01
400
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the natural history of Noncirrhotic Portal Hypertension (NCPH), a liver condition that raises pressure in liver blood vessels without cirrhosis. The study aims to understand how NCPH develops and progresses over time, identify new biomarkers, and improve patient monitoring and treatment decisions. It also investigates genetic factors, bile acids, lipids, and microbiome characteristics related to NCPH. Participants include people aged 12 and older who have NCPH or are at risk of developing it due to underlying diseases. The study involves two initial screening visits with medical history, physical exams, urine and stool tests, ultrasound, Fibroscan, blood tests, MRI, echocardiogram, liver biopsy, and hepatic venous portal gradient (HVPG) pressure measurement. Those with NCPH will have regular endoscopy and repeat testing every 2 to 4 years, while those without will have periodic imaging and biopsy to monitor for disease development. During the study, participants visit the clinic every 6 months for exams and blood tests, with yearly repeat of some screening tests. The study will last indefinitely to follow disease progression. Researchers measure liver stiffness, portal pressure, and gather questionnaire data to assess NCPH development. Safety and health monitoring continue throughout, including tracking for liver cancer and other complications.
CONDITIONS
Brief Title
Natural History of Noncirrhotic Portal Hypertension
Who Can Participate
Age: 12Years - 100Years
All Genders
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older, and minors aged 12 to 17 years
- Women of childbearing potential must agree to use birth control unless menopausal or had hysterectomy
- Known diagnosis of Noncirrhotic Portal Hypertension or at risk due to underlying diseases such as CGD, SCD, Mastocytosis, CVID, CF, and CHF
You will not qualify if you...
- Pregnancy
- Other liver diseases that typically cause cirrhosis
- Active Chronic Hepatitis B infection with elevated viral load
- Hepatitis C infection
- Liver diseases like primary sclerosing cholangitis, primary biliary cirrhosis, Wilson's disease, autoimmune hepatitis
- Hemochromatosis with specific biopsy or genetic findings
- Bile duct obstruction within the last six months
- Confirmed cirrhosis by liver biopsy
- Active substance abuse in the past year
- Evidence of liver cancer or cholangiocarcinoma
- Any severe condition that would prevent study participation or compliance
- Inability to comply or give written informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surveillance
Duration - Up to 5 years
Participants are observed over time to understand the development and progression of noncirrhotic portal hypertension and to identify relevant biomarkers.
Periodic visits depending on disease status and study assessments
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
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Research Team
J
Jaha F Norman-Wheeler
T
Theo Heller, M.D.
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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Published Research Related To This Trial
Noncirrhotic portal fibrosis/idiopathic portal hypertension: APASL recommendations for diagnosis and treatment.
Shiv Kumar Sarin, Ashish Kumar, Yogesh Kumar Chawla...
https://pubmed.ncbi.nlm.nih.gov/19669336Idiopathic noncirrhotic portal hypertension.
Jeoffrey N L Schouten, Juan C Garcia-Pagan, Dominique C Valla...
https://pubmed.ncbi.nlm.nih.gov/21574171