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Vascular Liver Disease Evaluation, Follow Up and Non-Invasive Diagnostics Program (VALID)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03717792
Recruitment Status : Recruiting
First Posted : October 24, 2018
Last Update Posted : October 24, 2018
Sponsor:
Information provided by (Responsible Party):
Jonel Trebicka, University Hospital, Bonn

Brief Summary:

Background Vascular liver disorders (VALDI) are rare diseases, for which knowledge on risk factors, appropriate methods of diagnosis, effect of therapy and prognosis still need to be improved.

Aim of the study This project aims to study risk factors, methods of detection, therapy and prognosis in order to elaborate and disseminate updated recommendations for the optimal management of patients with VALDI.

Design of the study Data on patients will be collected from baseline (the date of diagnosis) up to 3 years. During this period, data on clinical condition, laboratory results, diagnostic tests, interventions and outcome will be collected anonymously using standardised review of medical charts by one special trained investigator. Only patients with VALDI are eligible to participate.


Condition or disease Intervention/treatment
Vascular Disorder of Liver Other: no intervention

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Vascular Liver Disease Evaluation, Follow Up and Non-Invasive Diagnostics Program
Actual Study Start Date : January 1, 2010
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Diseases


Intervention Details:
  • Other: no intervention
    no intervention


Primary Outcome Measures :
  1. Complications of Portal Hypertension [ Time Frame: up to 3 years ]
    Ascites, Varices, Bleeding, Encephalpathy, Thrombosis


Secondary Outcome Measures :
  1. Mortality [ Time Frame: up to 3 years ]
    Survival



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
We include all patients above 18 years of age with vascular liver disease diagnosed according to EASL Clinical Practice Guideline.
Criteria

Inclusion Criteria:

  • all patients with vascular liver disease

Exclusion Criteria:

  • patients without vascular liver disease

Information from the National Library of Medicine

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): NCT03717792


Contacts
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Contact: Michael Praktiknjo, MD +4922828715770 michael.praktiknjo@ukbonn.de
Contact: Jonel Trebicka, MD, PhD +496963014256 jonel.trebicka@kgu.de

Locations
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Germany
University Hospital Bonn Recruiting
Bonn, Germany
Contact: Michael Praktiknjo, MD    +49228 28715770    michael.praktiknjo@ukbonn.de   
Sponsors and Collaborators
University Hospital, Bonn

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Responsible Party: Jonel Trebicka, Professor, University Hospital, Bonn
ClinicalTrials.gov Identifier: NCT03717792    
Other Study ID Numbers: VALID
First Posted: October 24, 2018    Key Record Dates
Last Update Posted: October 24, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Diseases
Vascular Diseases
Digestive System Diseases
Cardiovascular Diseases