Natural History of Noncirrhotic Portal Hypertension
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|ClinicalTrials.gov Identifier: NCT02417740|
Recruitment Status : Recruiting
First Posted : April 16, 2015
Last Update Posted : December 22, 2020
- 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.
- To learn more about how NCPH develops over time.
- 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.
- 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
- 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.
|Condition or disease|
|Cystic Fibrosis Immunologic Deficiency Syndrome Turner Syndrome Congenital Hepatic Fibrosis Idiopathic Non-Cirrhotic Portal Hypertension|
|Study Type :||Observational|
|Estimated Enrollment :||400 participants|
|Official Title:||Natural History of Noncirrhotic Portal Hypertension|
|Actual Study Start Date :||July 25, 2015|
|Estimated Primary Completion Date :||September 4, 2029|
|Estimated Study Completion Date :||September 4, 2029|
Adult with absence of Portal Hypertension
Confirmed absence of Portal Hypertension will have no findings suggestive of non cirrhotic portal hypertension on liver biopsy and on portal pressure measurements on confirmatory examination.
Adult with presence of Portal Hypertension
Confirmed Presence of Noncirrhotic Portal Hypertension, through confirmatory testing, tissue diagnosis by liver biopsy and/or portal hypertension (HVPG >5mmHg).
Minors likely to have the absence of Portal Hypertension
Minors identified as Confirmed Absence of Noncirrhotic Portal Hypertension will have no abnormal findings on confirmatory examination.
Minors likely to have the presence of Portal Hypertension
Minors identified as Confirmed Presence of Noncirrhotic Portal Hypertension, have shown they have the disease with a tissue diagnosis by liver biopsy and/or portal hypertension (HVPG >5).
- To study the natural history of non cirrhotic portal hypertension. It is an ongoing study [ Time Frame: Ongoing ]natural history study
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02417740
|Contact: Jaha F Norman-Wheeler||(301) email@example.com|
|Contact: Theo Heller, M.D.||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 email@example.com|
|Principal Investigator:||Theo Heller, M.D.||National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|