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Natural History of Noncirrhotic Portal Hypertension

NCT02417740 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 400

Last updated 2026-05-12

No results posted yet for this study

Summary

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

  • Cystic Fibrosis
  • Immunologic Deficiency Syndrome
  • Turner Syndrome
  • Congenital Hepatic Fibrosis
  • Idiopathic Non-Cirrhotic Portal Hypertension

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    lead NIH

Principal Investigators

  • Theo Heller, M.D. · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Eligibility

Min Age
12 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-27
Primary Completion
2029-09-04
Completion
2029-09-04

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02417740 on ClinicalTrials.gov