Portal Hypertension in Non-alcoholic Fatty Liver Disease: Association With Cardiovascular Risk and Identification of Non-invasive Biomarkers (THESIS)
NCT ID: NCT04191044
Last Updated: 2019-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
170 participants
OBSERVATIONAL
2020-01-10
2020-07-10
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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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.
A complete cardiovascular and liver characterization will be carried out
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.
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.
A complete cardiovascular and liver characterization will be carried out
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.
NAFLD with advanced fibrosis
NAFLD with advanced fibrosis (i.e. grade 3 or 4 fibrosis) without previous portal hypertension-related complications
A complete cardiovascular and liver characterization will be carried out
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.
Decompensated NAFLD cirrhosis
Decompensated NAFLD cirrhosis (i.e. development of ascites, variceal hemorrhage, and/or hepatic encephalopathy) up to Child B (9 points)
A complete cardiovascular and liver characterization will be carried out
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.
Interventions
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A complete cardiovascular and liver characterization will be carried out
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.
Eligibility Criteria
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Inclusion Criteria
* Clinical suspicion of NAFLD.
* Severe (controlled attenuation parameter (CAP) ≥330 dB/m) or mild steatosis (CAP: 298-317 dB / m), and FibroScan® grade 2 fibrosis (M probe: 7-9 kpa; XL probe: 5-7.5 kpa) in patients with grade 1 or 2 obesity and insulin resistance (HOMA index\> 2.6) or diabetes mellitus.
* Fibroscan® grade 3 or 4 fibrosis (M probe:\> 9 kpa; XL probe:\> 7.5 kpa).
* Decompensated NAFLD cirrhosis (i.e. development of ascites, variceal hemorrhage, and/or hepatic encephalopathy) up to Child B (9 points).
* Signature of informed consent.
Exclusion Criteria
* Excessive alcohol consumption (≥ 30 grams per day in men and ≥ 20 grams per day in women).
* Comorbidities (HIV infection, connective diseases, prothrombotic disorders) and/or drugs (didanosine, azathioprine, oxaliplatin) associated with the presence of idiopathic non-cirrhotic portal hypertension.
* Clinical history of cardiovascular disease (ischemic cardiomyopathy, atrial fibrillation, valvular defects, severe arterial hypertension, previous hospitalizations secondary to heart failure, cerebrovascular disease).
* Severe renal impairment, defined by creatinine clearance \<15 ml/min/1.73m2.
* Any previous or current thrombosis in any venous territory.
* Uncontrolled psychiatric illness
* Contraindication to liver biopsy or any of the complementary tests included in the project.
* Hepatocellular carcinoma that does not meet Milan criteria.
* Pregnancy or breastfeeding
* Significant comorbidities that entail a functional limitation and/or a life expectancy of less than 12 months.
18 Years
65 Years
ALL
No
Sponsors
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Hospital Universitario Ramon y Cajal
OTHER
Hospital General Universitario Gregorio Marañon
OTHER
Puerta de Hierro University Hospital
OTHER
Instituto de Investigación Marqués de Valdecilla
OTHER
Responsible Party
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Central Contacts
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References
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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.
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.
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.
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.
Other Identifiers
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THESIS
Identifier Type: -
Identifier Source: org_study_id