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Status unknownNCT04191044THESISUpdated Dec 12, 2019

Portal Hypertension in Non-alcoholic Fatty Liver Disease: Association With Cardiovascular Risk and Identification of Non-invasive Biomarkers (THESIS)

An observational study in Fatty Liver Disease, sponsored by Instituto de Investigación Marqués de Valdecilla. Status unknown. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-12-12.

Sponsored by Instituto de Investigación Marqués de Valdecilla · Observational

The sponsor has not verified this record recently (last verified Dec 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
170
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Fatty Liver Disease

Keywords

  • Non-alcoholic fatty liver disease
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In context

Liver Diseases

2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.

This study's planned enrollment of 170 is close to the median of 167 across 681 observational studies indexed under Liver Diseases.

Browse Liver Diseases studies →

Lead sponsor

Instituto de Investigación Marqués de Valdecilla is the lead sponsor of 32 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Non-alcoholic fatty liver disease.

Inclusion criteria

  • Age between 18 and 65 years.
  • 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

Exclusion Criteria:

  • Concomitant liver disease and patients with acute on chronic liver failure.
  • 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.
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
170 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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.

    Other: A complete cardiovascular and liver characterization will be carried out

  • 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.

    Other: A complete cardiovascular and liver characterization will be carried out

  • NAFLD with advanced fibrosis

    NAFLD with advanced fibrosis (i.e. grade 3 or 4 fibrosis) without previous portal hypertension-related complications

    Other: A complete cardiovascular and liver characterization will be carried out

  • Decompensated NAFLD cirrhosis

    Decompensated NAFLD cirrhosis (i.e. development of ascites, variceal hemorrhage, and/or hepatic encephalopathy) up to Child B (9 points)

    Other: A complete cardiovascular and liver characterization will be carried out

Interventions

  • OtherA 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.

06

What researchers measure

Primary outcomes

  1. Number of patients with NAFLD without advanced fibrosis and severe steatosis with portal hypertension

    Time frame: 1 months

  2. Number of patients with NAFLD and advanced fibrosis with portal hypertension

    Time frame: 1 months

  3. 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.

    Time frame: 1 months

  4. Threshold of portal hypertension leading to portal hypertension-related complications in patients with NAFLD

    Time frame: 1months

Secondary outcomes

  1. Impact of portal hypertension and hepatic fibrosis on early cardiovascular risk and the degree of liver and kidney function.

    Time frame: 1 months

  2. Non-invasive biomarkers of the presence and severity of portal hypertension through metabolomics, extracellular vesicles and / or other analytical markers

    liquid biopsy

    Time frame: 1 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 29368124 ↗
  • 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. PubMed 21389796 ↗
  • 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. PubMed 22610002 ↗
  • 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. PubMed 30625404 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 12, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04191044
Lead sponsor
Instituto de Investigación Marqués de Valdecilla
Collaborators
Hospital Universitario Ramon y Cajal, Hospital General Universitario Gregorio Marañon, Puerta de Hierro University Hospital
Responsible party
Sponsor
First posted
Dec 9, 2019
Start date
Jan 10, 2020 (estimated)
Primary completion
Jan 10, 2020 (estimated)
Completion
Jul 10, 2020 (estimated)
Last update
Dec 12, 2019

Study contacts

Jose Ignacio Fortea
Contact
jifortea@gmail.com
+34 942 204084
Lucia Lavin Alconero
Contact
eclinicos5@idival.org
+34 942 204084

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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