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| Name | Class |
|---|---|
| Hospital Universitario Ramon y Cajal | OTHER |
| Hospital General Universitario Gregorio Marañon | OTHER |
| Puerta de Hierro University Hospital | OTHER |
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Non-alcoholic fatty liver disease (NAFLD) is the most frequent cause of chronic liver disease in our environment. Preliminary data suggest that portal hypertension may exist in the initial phases of NAFLD due to mechanisms that have not yet been elucidated. The clinical relevance of its development in these initial phases is unknown, while in more advanced phases new data are required to confirm the close relationship between portal hypertension and the risk of decompensation described in other etiologies. Likewise, the influence of fibrosis and portal hypertension on the cardiovascular risk of patients with NAFLD is unknown. The aim of the present multicenter project is to characterize the presence of portal hypertension and the mechanisms involved in its development in the different stages of NAFLD, to assess the association between the degree of portal hypertension and the development of portal hypertension-related complications, to know the early cardiovascular risk in the different stages of the disease, and to identify noninvasive biomarkers of the presence and severity of portal hypertension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NAFLD with mild steatosis and grade <3 fibrosis in patients | NAFLD with mild steatosis and grade <3 fibrosis in patients with grade 1 or 2 obesity and insulin resistance (HOMA index> 2.6) or diabetes mellitus. |
| |
| NAFLD with severe steatosis and grade <3 fibrosis in patients | NAFLD with severe steatosis and grade <3 fibrosis in patients with grade 1 or 2 obesity and insulin resistance (HOMA index> 2.6) or diabetes mellitus. |
| |
| NAFLD with advanced fibrosis | NAFLD with advanced fibrosis (i.e. grade 3 or 4 fibrosis) without previous portal hypertension-related complications |
| |
| Decompensated NAFLD cirrhosis | Decompensated NAFLD cirrhosis (i.e. development of ascites, variceal hemorrhage, and/or hepatic encephalopathy) up to Child B (9 points) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A complete cardiovascular and liver characterization will be carried out | Other | A complete cardiovascular and liver characterization will be carried out, including some supplementary tests with minimal risks (e.g. hemodynamic study). If any disease is detected, patients will be referred to the corresponding specialized care following the usual clinical practice. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with NAFLD without advanced fibrosis and severe steatosis with portal hypertension | 1 months | |
| Number of patients with NAFLD and advanced fibrosis with portal hypertension | 1 months | |
| number of the mechanisms responsible for the appearance of portal hypertension by specifically assessing the following | An increase in sinusoidal vascular resistance and the relative importance of its structural (sinusoidal compression) and functional (endothelial dysfunction and activation of starry cells) components, Splanchnic vasodilatation leading to portal hyperflow and hyperdynamic circulation, proinflammatory state and Activation of angiogenesis. | 1 months |
| Threshold of portal hypertension leading to portal hypertension-related complications in patients with NAFLD | 1months |
| Measure | Description | Time Frame |
|---|---|---|
| Impact of portal hypertension and hepatic fibrosis on early cardiovascular risk and the degree of liver and kidney function. | 1 months | |
| Non-invasive biomarkers of the presence and severity of portal hypertension through metabolomics, extracellular vesicles and / or other analytical markers |
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Inclusion Criteria:
Exclusion Criteria:
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Non-alcoholic fatty liver disease.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jose Ignacio Fortea | Contact | +34 942 204084 | jifortea@gmail.com | |
| Lucia Lavin Alconero | Contact | +34 942 204084 | eclinicos5@idival.org |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29368124 | Background | Baffy G. Origins of Portal Hypertension in Nonalcoholic Fatty Liver Disease. Dig Dis Sci. 2018 Mar;63(3):563-576. doi: 10.1007/s10620-017-4903-5. Epub 2018 Jan 22. | |
| 21389796 | Background | Francque S, Verrijken A, Mertens I, Hubens G, Van Marck E, Pelckmans P, Van Gaal L, Michielsen P. Noncirrhotic human nonalcoholic fatty liver disease induces portal hypertension in relation to the histological degree of steatosis. Eur J Gastroenterol Hepatol. 2010 Dec;22(12):1449-57. doi: 10.1097/MEG.0b013e32833f14a1. |
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Blood samples will be used to measure inflammation markers and other laboratory parameters.
|
liquid biopsy
| 1 months |
| 22610002 | Background | Mendes FD, Suzuki A, Sanderson SO, Lindor KD, Angulo P. Prevalence and indicators of portal hypertension in patients with nonalcoholic fatty liver disease. Clin Gastroenterol Hepatol. 2012 Sep;10(9):1028-33.e2. doi: 10.1016/j.cgh.2012.05.008. Epub 2012 May 18. |
| 30625404 | Background | Rodrigues SG, Montani M, Guixe-Muntet S, De Gottardi A, Berzigotti A, Bosch J. Patients With Signs of Advanced Liver Disease and Clinically Significant Portal Hypertension Do Not Necessarily Have Cirrhosis. Clin Gastroenterol Hepatol. 2019 Sep;17(10):2101-2109.e1. doi: 10.1016/j.cgh.2018.12.038. Epub 2019 Jan 6. |
| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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